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FDA 510(k)

EQ-PRC LC WARFARIN GENOTYPING KIT

K-Number: K073071 · 2009-02-06

ApplicantTrimgen Corporation
Decision Date2009-02-06
Product CodeODW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EQ-PRC LC WARFARIN GENOTYPING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Trimgen Corporation. It received FDA 510(k) clearance on 2009-02-06 under 510(k) number K073071. The device is classified under product code ODW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EQ-PRC LC WARFARIN GENOTYPING KIT?

EQ-PRC LC WARFARIN GENOTYPING KIT is a medical device that received FDA 510(k) clearance on 2009-02-06. The listed applicant is Trimgen Corporation. The 510(k) number is K073071.

When did EQ-PRC LC WARFARIN GENOTYPING KIT receive FDA 510(k) clearance?

EQ-PRC LC WARFARIN GENOTYPING KIT received FDA 510(k) clearance on 2009-02-06, under 510(k) number K073071.

Who is the listed applicant for EQ-PRC LC WARFARIN GENOTYPING KIT?

The FDA 510(k) record lists Trimgen Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EQ-PRC LC WARFARIN GENOTYPING KIT?

The FDA product code for EQ-PRC LC WARFARIN GENOTYPING KIT is ODW.

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Related Devices (Code: ODW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183530TruDiagnosis SystemAkonni Biosystems, Inc.K152612eSensor Warfarin Sensitivity Saliva TestGenmark Diagnostics, IncorporatedK073720ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENTOsmetech Molecular DiagnosticsK073014INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARINAutogenomics, IncorporatedK070804VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TESTNanosphere, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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