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FDA 510(k)

ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT

K-Number: K073720 · 2008-07-17

ApplicantOsmetech Molecular Diagnostics
Decision Date2008-07-17
Product CodeODW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Osmetech Molecular Diagnostics. It received FDA 510(k) clearance on 2008-07-17 under 510(k) number K073720. 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 ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT?

ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT is a medical device that received FDA 510(k) clearance on 2008-07-17. The listed applicant is Osmetech Molecular Diagnostics. The 510(k) number is K073720.

When did ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT receive FDA 510(k) clearance?

ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT received FDA 510(k) clearance on 2008-07-17, under 510(k) number K073720.

Who is the listed applicant for ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT?

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

What is the FDA product code for ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT?

The FDA product code for ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT is ODW.

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Other records listing Osmetech Molecular Diagnostics 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.

K093974ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPINGK090901ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8

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 CorporationK073014INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARINAutogenomics, IncorporatedK070804VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TESTNanosphere, Inc.

Official Source

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

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