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FDA 510(k)

INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN

K-Number: K073014 · 2008-01-23

ApplicantAutogenomics, Incorporated
Decision Date2008-01-23
Product CodeODW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN is the device name listed in this FDA 510(k) record. The listed applicant is Autogenomics, Incorporated. It received FDA 510(k) clearance on 2008-01-23 under 510(k) number K073014. 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 INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN?

INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN is a medical device that received FDA 510(k) clearance on 2008-01-23. The listed applicant is Autogenomics, Incorporated. The 510(k) number is K073014.

When did INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN receive FDA 510(k) clearance?

INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN received FDA 510(k) clearance on 2008-01-23, under 510(k) number K073014.

Who is the listed applicant for INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN?

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

What is the FDA product code for INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN?

The FDA product code for INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN is ODW.

Related Clinical Trials

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.

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Other records listing Autogenomics, Incorporated as applicant

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.

K101683INFINITI CYP2C19 ASSAY

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, IncorporatedK073071EQ-PRC LC WARFARIN GENOTYPING KITTrimgen CorporationK073720ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENTOsmetech Molecular DiagnosticsK070804VERIGENE 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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