DPJ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
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| Record | Firm | Date | Builder |
|---|---|---|---|
| ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET (K913911) | Roche Diagnostic Systems, Inc. | 1991-11-01 | + Add |
| ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE (K912754) | Roche Diagnostic Systems, Inc. | 1991-09-27 | + Add |
Track DPJ automatically
Every clearance here is in the API, with alerts when new ones post.