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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 K924136
Device Name PREMIER C. DIFFICILE TOXIN A CONTROLS
Applicant
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Applicant Contact ALLEN D NICKOL
Correspondent
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Correspondent Contact ALLEN D NICKOL
Regulation Number866.2660
Classification Product Code
LLH  
Date Received08/18/1992
Decision Date 10/19/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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