ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
FDA 510(k) clearance K951595 · decided 1995-09-08
Clearance details
- K-number
- K951595
- Device name
- ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
- Applicant
- Roche Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-06
- Decision date
- 1995-09-08
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- CGX
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28 recall (Z-0168-2014) | Roche Diagnostics Operations, Inc. | 2013-11-05 |
| Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer. recall (Z-0696-2013) | Roche Diagnostics Operations, Inc. | 2013-01-18 |
| Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, I recall (Z-0007-2009) | Roche Diagnostics Corp. | 2008-10-09 |
| Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianap recall (Z-0012-2009) | Roche Diagnostics Corp. | 2008-10-09 |
| COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system I recall (Z-0667-03) | Roche Diagnostics Corp. | 2003-03-21 |