TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
FDA 510(k) clearance K974881 · decided 1998-03-20
Clearance details
- K-number
- K974881
- Device name
- TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
- Applicant
- Biosite Incorporated
- Decision
- Substantially Equivalent
- Date received
- 1997-12-30
- Decision date
- 1998-03-20
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- MCB
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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| 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
| Record | Firm | Date |
|---|---|---|
| Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPO recall (Z-1352-2008) | Biosite Inc | 2008-03-27 |