LCE
6 FDA 510(k) clearances · Product code
22 daysmedian time to decision
122 days90th percentile
6clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Netilmicin (I-125)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3450
- Medical specialty
- Clinical Toxicology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EMIT NETILMICIN ASSAY (K833715) | Syva Co. | 1983-12-27 |
| AMES TDA NETILMICIN TEST & SERUM (K832088) | Miles Laboratories, Inc. | 1983-10-28 |
| NETILMICIN FLUORESCENT IMMUNOASSAY (K822941) | American Diagnostic Corp. | 1982-10-26 |
| TDX NETILMICIN (K821698) | Abbott Laboratories | 1982-06-22 |
| MACRO-VUE CARD TEST, NETILMICIN (K821399) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-05-28 |
| EMIT AND NETILMICIN ASSAY (K820324) | Syva Co. | 1982-02-23 |
Track LCE automatically
Every clearance here is in the API, with alerts when new ones post.