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FDA 510(k)

ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING

K-Number: K093974 · 2010-04-22

ApplicantOsmetech Molecular Diagnostics
Decision Date2010-04-22
Product CodeNPQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING 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 2010-04-22 under 510(k) number K093974. The device is classified under product code NPQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING?

ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING is a medical device that received FDA 510(k) clearance on 2010-04-22. The listed applicant is Osmetech Molecular Diagnostics. The 510(k) number is K093974.

When did ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING receive FDA 510(k) clearance?

ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING received FDA 510(k) clearance on 2010-04-22, under 510(k) number K093974.

Who is the listed applicant for ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING?

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 ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING?

The FDA product code for ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING is NPQ.

Related Clinical Trials

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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.

K090901ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8K073720ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT

Related Devices (Code: NPQ)

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.

K100980INVADER FACTOR VHologic, Inc.K093129ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR IIIllumina, Inc.K082118XPERT HEMOSIL FACTOR II & FACTOR V ASSAYCepheidK060564INFINITI SYSTEMAutoGenomics, 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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