COBAS INTEGRA ACETAMINOPHEN
FDA 510(k) clearance K991598 · decided 1999-07-22
Clearance details
- K-number
- K991598
- Device name
- COBAS INTEGRA ACETAMINOPHEN
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-10
- Decision date
- 1999-07-22
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- LDP
- Device class
- 2
- Regulation number
- 862.3030
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Acetaminophen Test System for use on the COBAS/INTEGRA/cobas c, part number 20767174322, R recall (Z-1680-2011) | Roche Diagnostics Operations, Inc. | 2011-03-16 |
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|---|---|---|
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