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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 K883560
Device Name CDT CYTOTOXI TEST
Applicant
Advanced Clinical Diagnostics
3110 Drummond Rd.
Toledo,  OH  43606
Applicant Contact THOMBRE, PHD
Correspondent
Advanced Clinical Diagnostics
3110 Drummond Rd.
Toledo,  OH  43606
Correspondent Contact THOMBRE, PHD
Regulation Number866.2660
Classification Product Code
LLH  
Date Received08/19/1988
Decision Date 10/25/1988
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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