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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 K926442
Device Name PREMIER C. DIFFICILE, MODIFICATION
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 Received12/16/1992
Decision Date 01/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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