OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)— 510(k) K023677

Name: FDA 510(k) clearance K023677
Creator: U.S. Food and Drug Administration
Published: 2003-01-29

Substantially Equivalent

Osmetech

FDA 510(k) clearance K023677 for OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV), Substantially Equivalent on 2003-01-29. Applicant: Osmetech. Device class: 1.

Clearance details

Applicant: Osmetech
Product code: Code LIB
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2002-11-01
Decision date: 2003-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crewe, GB

Download summary PDF View on FDA.gov ↗

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