DJP — Radioimmunoassay, Amphetamine Class II
FDA Device Classification
Classification Details
- Product Code
- DJP
- Device Class
- Class II
- Regulation Number
- 862.3100
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K960526 | diagnostic reagents | PRIMIDONE EIA TEST | March 18, 1996 |
| K913866 | immunalysis corporation | URINE AMPHETAMINE DIRECT RIA KIT (I-125) | September 25, 1991 |
| K912755 | roche diagnostic systems | ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE | August 26, 1991 |
| K882228 | diagnostic products | REVISED DOUBLE ANTIBODY AMPHETAMINE | August 8, 1988 |
| K881817 | roche diagnostic systems | ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES | July 29, 1988 |
| K854009 | roche diagnostic systems | ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP | October 15, 1985 |
| K830482 | hoffmann-la roche | ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE | March 24, 1983 |
| K823212 | hoffmann-la roche | ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE | November 29, 1982 |
| K812986 | hoffmann-la roche | AGGLUTEX AMPHETAMINE TEST KIT | January 22, 1982 |