Cleared Traditional

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

K023677 · Osmetech · Microbiology

Jan 2003

Decision

89d

Days

Class 1

Risk

K023677 is an FDA 510(k) clearance for the OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV), a Device, General Purpose, Microbiology, Diagnostic (Class I — General Controls, product code LIB), submitted by Osmetech (Crewe, GB). The FDA issued a Cleared decision on January 29, 2003, 89 days after receiving the submission on November 1, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K023677 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 2002
Decision Date	January 29, 2003
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF