The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Abuscreen Radioimmunoassay-barbiturate.
| Device ID | K830479 |
| 510k Number | K830479 |
| Device Name: | ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE |
| Classification | Radioimmunoassay, Barbiturate |
| Applicant | HOFFMANN-LA ROCHE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DKN |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-15 |
| Decision Date | 1983-03-10 |