COBAS INTEGRA REAGENT CASSETTES
FDA 510(k) clearance K982382 · decided 1998-09-28
Clearance details
- K-number
- K982382
- Device name
- COBAS INTEGRA REAGENT CASSETTES
- Applicant
- Roche Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-08
- Decision date
- 1998-09-28
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- CFN
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vit recall (Z-0356-2007) | Roche Diagnostics Corp. | 2007-01-17 |