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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 K041003
Device Name IMMUNOCARD TOXINS A & B, MODEL 712050
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 RIVER HILLS DR.
CINCINNATI,  OH  45244
Applicant Contact SUSAN ROLIH
Correspondent
MERIDIAN BIOSCIENCE, INC.
3471 RIVER HILLS DR.
CINCINNATI,  OH  45244
Correspondent Contact SUSAN ROLIH
Regulation Number866.2660
Classification Product Code
LLH  
Date Received04/19/2004
Decision Date 08/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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