COBAS INTEGRA AMIKACIN MAB
FDA 510(k) clearance K991597 · decided 1999-07-22
Clearance details
- K-number
- K991597
- Device name
- COBAS INTEGRA AMIKACIN MAB
- 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
- LGJ
- Device class
- 2
- Regulation number
- 862.3035
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| COBAS-FP REAGENTS AND CALIBRATORS (K941712) | Roche Diagnostic Systems, Inc. | 1994-06-13 |
| AMIKACIN KIT (FPIA) (K862248) | Windsor Laboratories, Inc. | 1986-08-04 |
Recalls involving this device
No recalls on record reference this clearance.
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