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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 K911958
Device Name CYTOCLONE A & B EIA
Applicant
Cambridge Biotech Corp.
365 Plantation St.
Worcester,  MA  01605
Applicant Contact JACK CASSORLA
Correspondent
Cambridge Biotech Corp.
365 Plantation St.
Worcester,  MA  01605
Correspondent Contact JACK CASSORLA
Regulation Number866.2660
Classification Product Code
LLH  
Date Received05/03/1991
Decision Date 07/30/1991
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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