The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Abuscreen Radioimmunoassay For Amphetamine-high Sp.
| Device ID | K854009 |
| 510k Number | K854009 |
| Device Name: | ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP |
| Classification | Radioimmunoassay, Amphetamine |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 11 FRANKLIN AVE. Belleville, NJ 07109 -3597 |
| Contact | Kafader Ii |
| Correspondent | Kafader Ii ROCHE DIAGNOSTIC SYSTEMS, INC. 11 FRANKLIN AVE. Belleville, NJ 07109 -3597 |
| Product Code | DJP |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-30 |
| Decision Date | 1985-10-15 |