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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagents, Clostridium Difficile Toxin
510(k) Number K102242
Device Name OSOM C. DIFFICILE TOXIN A/B TEST
Applicant
Genzyme Corporation
31 New York Ave.
Framingham,  MA  01701
Applicant Contact CAROL C RYERSON
Correspondent
Genzyme Corporation
31 New York Ave.
Framingham,  MA  01701
Correspondent Contact CAROL C RYERSON
Regulation Number866.2660
Classification Product Code
LLH  
Date Received08/09/2010
Decision Date 12/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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