KJI
6 FDA 510(k) clearances · Product code
23 daysmedian time to decision
76 days90th percentile
6clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Kanamycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3520
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AMES TDA KANAMYCIN TEST-CONTROL SERUM (K832769) | Miles Laboratories, Inc. | 1983-09-29 |
| ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY (K823370) | Syva Co. | 1982-12-03 |
| KENAMYCIN FLUORESCENT IMMUNOASSAY FIA (K823062) | American Diagnostic Corp. | 1982-11-10 |
| TDX KENAMYCIN (K822808) | Abbott Laboratories | 1982-10-08 |
| RIA KIT, KANAMYCIN (K782125) | Diagnostic Products Corp. | 1979-01-10 |
| KANAMYCIN RIA (K772038) | Monitor Science Corp. | 1978-01-12 |
Track KJI automatically
Every clearance here is in the API, with alerts when new ones post.