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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 K905211
Device Name VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY
Applicant
Vitek Systems, Inc.
1022 Hingham St.
Rockland,  MA  02370
Applicant Contact CHERYL WINTERS-HEARD
Correspondent
Vitek Systems, Inc.
1022 Hingham St.
Rockland,  MA  02370
Correspondent Contact CHERYL WINTERS-HEARD
Regulation Number866.2660
Classification Product Code
LLH  
Date Received11/20/1990
Decision Date 10/11/1991
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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