DJP
9 FDA 510(k) clearances · Product code
41 daysmedian time to decision
92 days90th percentile
9clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- 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 |
|---|---|---|
| PRIMIDONE EIA TEST (K960526) | Diagnostic Reagents, Inc. | 1996-03-18 |
| URINE AMPHETAMINE DIRECT RIA KIT (I-125) (K913866) | Immunalysis Corporation | 1991-09-25 |
| ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE (K912755) | Roche Diagnostic Systems, Inc. | 1991-08-26 |
| REVISED DOUBLE ANTIBODY AMPHETAMINE (K882228) | Diagnostic Products Corp. | 1988-08-08 |
| ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES (K881817) | Roche Diagnostic Systems, Inc. | 1988-07-29 |
| ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP (K854009) | Roche Diagnostic Systems, Inc. | 1985-10-15 |
| ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (K830482) | Hoffmann-La Roche, Inc. | 1983-03-24 |
| ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE (K823212) | Hoffmann-La Roche, Inc. | 1982-11-29 |
| AGGLUTEX AMPHETAMINE TEST KIT (K812986) | Hoffmann-La Roche, Inc. | 1982-01-22 |
Track DJP automatically
Every clearance here is in the API, with alerts when new ones post.