FDA 510(k) Applications for Medical Device Product Code "MCB"
(Antigen, C. Difficile)

FDA 510(k) Number Applicant Device Name Decision Date
K132010 BIOMERIEUX SA VIDAS C DIFFICILE GDH 10/09/2013
K974881 BIOSITE INCORPORATED TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A 03/20/1998
K112048 MERIDIAN BIOSCIENCE, INC. IMMUNOCARD C. DIFFICILE GDH 12/16/2011
K110620 MERIDIAN BIOSCIENCE, INC. PREMIER C. DIFFICILE GDH 05/03/2011
K053572 TECHLAB, INC. C. DIFF QUIK CHEK 04/26/2006
K955067 UNIPATH LTD. CLEARVIEW C. DIFF A 09/13/1996


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