KLP
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Amikacin Serum Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3035
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ONLINE TDM AMIKA (K032279) | Roche Diagnostics Corp. | 2003-10-10 |
| 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 |
Track KLP automatically
Every clearance here is in the API, with alerts when new ones post.