The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Abuscreen(r) Ontrak(tm) For Barbiturates.
| Device ID | K881816 |
| 510k Number | K881816 |
| Device Name: | ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES |
| Classification | Radioimmunoassay, Barbiturate |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. ONE SUNSET AVE. Montclair, NJ 07042 |
| Contact | Adrienne Choma |
| Correspondent | Adrienne Choma ROCHE DIAGNOSTIC SYSTEMS, INC. ONE SUNSET AVE. Montclair, NJ 07042 |
| Product Code | DKN |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-28 |
| Decision Date | 1988-07-28 |