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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, General Purpose, Microbiology, Diagnostic
510(k) Number K023677
Device Name OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)
Applicant
Osmetech
Electra House Electra Way
Crewe,  GB
Applicant Contact ANDREW TUMMON
Correspondent
Osmetech
Electra House Electra Way
Crewe,  GB
Correspondent Contact ANDREW TUMMON
Regulation Number866.2660
Classification Product Code
LIB  
Subsequent Product Code
LRH  
Date Received11/01/2002
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
Predetermined Change
Control Plan Authorized		 No
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