MCB — Antigen, C. Difficile Class I
FDA Device Classification
Classification Details
- Product Code
- MCB
- Device Class
- Class I
- Regulation Number
- 866.2660
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K132010 | biomerieux | VIDAS C DIFFICILE GDH | October 9, 2013 |
| K112048 | meridian bioscience | IMMUNOCARD C. DIFFICILE GDH | December 16, 2011 |
| K110620 | meridian bioscience | PREMIER C. DIFFICILE GDH | May 3, 2011 |
| K053572 | techlab | C. DIFF QUIK CHEK | April 26, 2006 |
| K974881 | biosite incorporated | TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A | March 20, 1998 |
| K955067 | unipath | CLEARVIEW C. DIFF A | September 13, 1996 |
| K924062 | meridian diagnostics | MERITEC C. DIFFICILE CONTROLS | October 19, 1992 |
| K904329 | baxter healthcare | CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY | March 12, 1991 |
| K895915 | meridian diagnostics | MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM | March 12, 1990 |
| K833447 | bartels immunodiagnostic supplies | CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- | May 21, 1984 |