The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Abuscreen Radioimmunoassay For Morphine (high Cut-off).
| Device ID | K935055 |
| 510k Number | K935055 |
| Device Name: | ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) |
| Classification | Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Contact | Carol L Krieger |
| Correspondent | Carol L Krieger ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Product Code | DOE |
| CFR Regulation Number | 862.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-20 |
| Decision Date | 1994-08-09 |