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FDA 510(k)

OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)

K-Number: K023677 · 2003-01-29

ApplicantOsmetech
Decision Date2003-01-29
Product CodeLIB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) is the device name listed in this FDA 510(k) record. The listed applicant is Osmetech. It received FDA 510(k) clearance on 2003-01-29 under 510(k) number K023677. The device is classified under product code LIB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)?

OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) is a medical device that received FDA 510(k) clearance on 2003-01-29. The listed applicant is Osmetech. The 510(k) number is K023677.

When did OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) receive FDA 510(k) clearance?

OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) received FDA 510(k) clearance on 2003-01-29, under 510(k) number K023677.

Who is the listed applicant for OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)?

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

What is the FDA product code for OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)?

The FDA product code for OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) is LIB.

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 Osmetech 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.

K011043OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)

Related Devices (Code: LIB)

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.

K920416SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMBBehring Diagnostics, Inc.K912558GULL ELISAWAREGull Laboratories, Inc.K872273CORNING EASY WASH ELISA PLATESCorning Medical & ScientificK871559CELL LIFTERCorning Costar Corp.K864249NORMAL SALINE STERILEMds Laboratories, Inc.K863789CORNING ELISA PLATESCorning Medical & Scientific

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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