Panels › Microbiology › Product code MCB · Class 1
Antigen, C. Difficile
Regulation 866.2660
0510(k)s in 12 months (10 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in MCB
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2013 | K132010 | VIDAS C DIFFICILE GDH Biomerieux S.A., FR | MCB |
| Dec 16, 2011 | K112048 | IMMUNOCARD C. DIFFICILE GDH Meridian Bioscience, Inc. | MCB |
| May 3, 2011 | K110620 | PREMIER C. DIFFICILE GDH Meridian Bioscience, Inc. | MCB |
| Apr 26, 2006 | K053572 | C. DIFF QUIK CHEK Techlab, Inc. | MCB |
| Mar 20, 1998 | K974881 | TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A Biosite Incorporated | MCB |
| Sep 13, 1996 | K955067 | CLEARVIEW C. DIFF A Unipath , Ltd., GB | MCB |
| Oct 19, 1992 | K924062 | MERITEC C. DIFFICILE CONTROLS Meridian Diagnostics, Inc. | MCB |
| Mar 12, 1991 | K904329 | CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY Baxter Healthcare Corp | MCB |
| Mar 12, 1990 | K895915 | MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM Meridian Diagnostics, Inc. | MCB |
| May 21, 1984 | K833447 | CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- Bartels Immunodiagnostic Supplies, Inc. | MCB |
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