MCB
10 FDA 510(k) clearances · Product code
151 daysmedian time to decision
312 days90th percentile
10clearances measured
FDA profile
- Official device name
- Antigen, C. Difficile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VIDAS C DIFFICILE GDH (K132010) | Biomerieux S.A. | 2013-10-09 |
| IMMUNOCARD C. DIFFICILE GDH (K112048) | Meridian Bioscience, Inc. | 2011-12-16 |
| PREMIER C. DIFFICILE GDH (K110620) | Meridian Bioscience, Inc. | 2011-05-03 |
| C. DIFF QUIK CHEK (K053572) | Techlab, Inc. | 2006-04-26 |
| TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A (K974881) | Biosite Incorporated | 1998-03-20 |
| CLEARVIEW C. DIFF A (K955067) | Unipath , Ltd. | 1996-09-13 |
| MERITEC C. DIFFICILE CONTROLS (K924062) | Meridian Diagnostics, Inc. | 1992-10-19 |
| CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY (K904329) | Baxter Healthcare Corp | 1991-03-12 |
| MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM (K895915) | Meridian Diagnostics, Inc. | 1990-03-12 |
| CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- (K833447) | Bartels Immunodiagnostic Supplies, Inc. | 1984-05-21 |
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Every clearance here is in the API, with alerts when new ones post.