DKN
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Radioimmunoassay, Barbiturate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3150
- 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 |
|---|---|---|
| ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES (K914468) | Roche Diagnostic Systems, Inc. | 1991-10-30 |
| ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES (K881816) | Roche Diagnostic Systems, Inc. | 1988-07-28 |
| ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE (K830479) | Hoffmann-La Roche, Inc. | 1983-03-10 |
| AGGLUTEX BARBITURATES TEST KIT (K812988) | Hoffmann-La Roche, Inc. | 1981-12-31 |
Track DKN automatically
Every clearance here is in the API, with alerts when new ones post.