FDA 510(k) Applications for Medical Device Product Code "MCB"
|
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 |