IMMUNOCARD C. DIFFICILE GDH
FDA 510(k) clearance K112048 · decided 2011-12-16
Clearance details
- K-number
- K112048
- Device name
- IMMUNOCARD C. DIFFICILE GDH
- Applicant
- Meridian Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-07-18
- Decision date
- 2011-12-16
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- MCB
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VIDAS C DIFFICILE GDH (K132010) | Biomerieux S.A. | 2013-10-09 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.