OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)


Device Classification Name

device, general purpose, microbiology, diagnostic

510(k) Number K023677
Device Name OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)
Original Applicant
OSMETECH
electra house electra way
crewe, 

GB

Original Contact andrew tummon
Regulation Number 866.2660
Classification Product Code
LIB  
Subsequent Product Code
LRH  
Date Received 11/01/2002
Decision Date 01/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No