Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-Bv)

FDA 510(k) K023677 · Osmetech

Substantially Equivalent

510(k) numberK023677

Submission

Device name
Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-Bv)
Applicant
Osmetech
Crewe, GB
Received
November 1, 2002
Decision date
January 29, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LIB – Device, General Purpose, Microbiology, Diagnostic
Device class
Class I (low risk)
Regulation
21 CFR 866.2660
Specialty
Microbiology

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Questions and answers

When was Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-Bv) cleared by the FDA?

Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-Bv) (K023677) received a 510(k) decision of Substantially Equivalent on January 29, 2003, 89 days after the submission was received.

What is the product code of K023677?

The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.