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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, C. Difficile
510(k) Number K955067
Device Name CLEARVIEW C. DIFF A
Applicant
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Applicant Contact Louise Roberts
Correspondent
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Correspondent Contact Louise Roberts
Regulation Number866.2660
Classification Product Code
MCB  
Date Received11/06/1995
Decision Date 09/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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