The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Abuscreen Online Ii For Opiates 300/2000, Abuscreen Online Opiates Calibration Pack, Abuscreen Online Opiates Control.
| Device ID | K974840 |
| 510k Number | K974840 |
| Device Name: | ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Contact | James W Haynes |
| Correspondent | James W Haynes ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Product Code | DJG |
| Subsequent Product Code | DJJ |
| Subsequent Product Code | DLR |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-24 |
| Decision Date | 1998-04-24 |
| Summary: | summary |