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idK153137_s0_e2000
K153137.txt
purpose for submission
Clearance of a new device
STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Es...
idK153137_s0_e2000
K153137.txt
measurand
Anti-PF4/Heparin Total Antibodies
STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Es...
idK153137_s0_e2000
K153137.txt
type of test
Automated, latex enhanced immuno-turbidimetric assay
SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary an...
idK153137_s0_e2000
K153137.txt
classification
Class II
) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary a...
idK153137_s0_e2000
K153137.txt
panel
Hematology (81)
k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary ...
idK153137_s0_e2000
K153137.txt
predicate device name
Asserachrom HPIA Test kit from Diagnostica Stago
STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Es...
idK153137_s0_e2000
K153137.txt
applicant
Instrumentation Laboratory (IL) Co.
) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary a...
idK153137_s8000_e10000
K153137.txt
proposed labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
...
idK153137_s8000_e10000
K153137.txt
conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
...
idK150041_s0_e2000
K150041.txt
purpose for submission
Clearance of a new device
STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietar...
idK150041_s0_e2000
K150041.txt
measurand
Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation
STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietar...
idK150041_s0_e2000
K150041.txt
type of test
Whole blood hemostasis
SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Propri...
idK150041_s0_e2000
K150041.txt
classification
Class II
) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Propr...
idK150041_s0_e2000
K150041.txt
panel
Hematology (81)
k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Prop...
idK150041_s0_e2000
K150041.txt
predicate device name
Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation
STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietar...
idK150041_s0_e2000
K150041.txt
applicant
Coramed Technologies, LLC
) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Propr...
idK150041_s8000_e10000
K150041.txt
proposed labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
...
idK150041_s8000_e10000
K150041.txt
conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
...
idK143329_s0_e2000
K143329.txt
purpose for submission
To obtain clearance for a new device, Amplivue® Trichomonas Assay
STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-depend...
idK143329_s0_e2000
K143329.txt
measurand
A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA
STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-depend...
idK143329_s0_e2000
K143329.txt
type of test
Nucleic acid amplification assay (Helicase-dependent Amplification, HDA)
SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-de...
idK143329_s0_e2000
K143329.txt
classification
Class II
) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-d...
idK143329_s0_e2000
K143329.txt
product code
OUY - Trichomonas vaginalis nucleic acid amplification test system
) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-d...
idK143329_s0_e2000
K143329.txt
panel
83 - Microbiology
k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-...
idK143329_s0_e2000
K143329.txt
intended use
The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females...
SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-de...
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This dataset is adapted from the paper Language Models Enable Simple Systems for Generating Structured Views of Heterogeneous Data Lakes. You can learn more about the data collection process there.

Please consider citing the following if you use this task in your work:

@article{arora2024simple,
  title={Simple linear attention language models balance the recall-throughput tradeoff},
  author={Arora, Simran and Eyuboglu, Sabri and Zhang, Michael and Timalsina, Aman and Alberti, Silas and Zinsley, Dylan and Zou, James and Rudra, Atri and Ré, Christopher},
  journal={arXiv:2402.18668},
  year={2024}
}
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