DKN — Radioimmunoassay, Barbiturate Class II
FDA Device Classification
Classification Details
- Product Code
- DKN
- Device Class
- Class II
- Regulation Number
- 862.3150
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K914468 | roche diagnostic systems | ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES | October 30, 1991 |
| K881816 | roche diagnostic systems | ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES | July 28, 1988 |
| K830479 | hoffmann-la roche | ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE | March 10, 1983 |
| K812988 | hoffmann-la roche | AGGLUTEX BARBITURATES TEST KIT | December 31, 1981 |