LDN
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Enzymatic Radiochemical Assay, Amikacin
- 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 |
|---|---|---|
| AMIKACIN REAGENT TEST KIT (K840647) | Beckman Instruments, Inc. | 1984-04-02 |
| MODIFICATION OF EMIT AND AMIKACIN ASSAY (K833546) | Syva Co. | 1983-12-08 |
| EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO (K820440) | Syva Co. | 1982-03-15 |
Track LDN automatically
Every clearance here is in the API, with alerts when new ones post.