Product code DPJ
- Device name
- Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3100
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K913911 | ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET | Roche Diagnostic Systems, Inc. | 1991-11-01 |
| K912754 | ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE | Roche Diagnostic Systems, Inc. | 1991-09-27 |