Radioimmunoassay, Amphetamine
FDA product code DJP · Class II (moderate risk) · 21 CFR 862.3100 · Clinical Toxicology
9510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960526 | Primidone Eia TestDJP · Traditional | Diagnostic Reagents, Inc. | 03/18/1996SE |
| K913866 | Urine Amphetamine Direct Ria Kit (I-125)DJP · Traditional | Immunalysis Corporation | 09/25/1991SE |
| K912755 | Abuscreen Radioimmunoassay for AmphetamineDJP · Traditional | Roche Diagnostic Systems, Inc. | 08/26/1991SE |
| K882228 | Revised Double Antibody AmphetamineDJP · Traditional | Diagnostic Products Corp. | 08/08/1988SE |
| K881817 | Abuscreen(R) Ontrak(Tm) for AmphetaminesDJP · Traditional | Roche Diagnostic Systems, Inc. | 07/29/1988SE |
| K854009 | Abuscreen Radioimmunoassay for Amphetamine-High SPDJP · Traditional | Roche Diagnostic Systems, Inc. | 10/15/1985SE |
| K830482 | Abuscreen Radioimmunoassay-AmphetamineDJP · Traditional | Hoffmann-La Roche, Inc. | 03/24/1983SE |
| K823212 | Abuscreen Radioimmunoassay - AmphetamineDJP · Traditional | Hoffmann-La Roche, Inc. | 11/29/1982SE |
| K812986 | Agglutex Amphetamine Test KitDJP · Traditional | Hoffmann-La Roche, Inc. | 01/22/1982SE |