ONLINE TDM AMIKA
FDA 510(k) clearance K032279 · decided 2003-10-10
Clearance details
- K-number
- K032279
- Device name
- ONLINE TDM AMIKA
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-24
- Decision date
- 2003-10-10
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- KLP
- 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 |
|---|---|---|
| EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 (K873426) | Em Diagnostic Systems, Inc. | 1987-10-29 |
| BACTEC (K790899) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1979-05-23 |
| BIO-MONITOR AMIKACIN (K780949) | Monitor Science Corp. | 1978-08-14 |
Recalls involving this device
No recalls on record reference this clearance.
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