ROCHE COBAS AMPLICOR ANALYZER
FDA 510(k) clearance K964506 · decided 1997-05-21
Clearance details
- K-number
- K964506
- Device name
- ROCHE COBAS AMPLICOR ANALYZER
- Applicant
- Roche Molecular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-08
- Decision date
- 1997-05-21
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- JJF
- Device class
- 1
- Regulation number
- 862.2170
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Branchburg, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests recall (Z-1106-2007) | Roche Molecular Systems, Inc. | 2007-08-02 |
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