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FDA 510(k)

VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST

K-Number: K070804 · 2007-09-17

ApplicantNanosphere, Inc.
Decision Date2007-09-17
Product CodeODW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST is the device name listed in this FDA 510(k) record. The listed applicant is Nanosphere, Inc.. It received FDA 510(k) clearance on 2007-09-17 under 510(k) number K070804. 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 VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST?

VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST is a medical device that received FDA 510(k) clearance on 2007-09-17. The listed applicant is Nanosphere, Inc.. The 510(k) number is K070804.

When did VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST receive FDA 510(k) clearance?

VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST received FDA 510(k) clearance on 2007-09-17, under 510(k) number K070804.

Who is the listed applicant for VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST?

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

What is the FDA product code for VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST?

The FDA product code for VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST is ODW.

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Other records listing Nanosphere, Inc. 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.

K123197VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)K120466VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)K122514VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TESTK112424VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)K103209VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)K093337VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM

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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, IncorporatedK073071EQ-PRC LC WARFARIN GENOTYPING KITTrimgen CorporationK073720ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENTOsmetech Molecular DiagnosticsK073014INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARINAutogenomics, Incorporated

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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