The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Abuscreen Online For Opiates 1000 Test Kit-2000 Ng/ml Cutoff Olympus Au800 Instrument Application.
| Device ID | K951319 |
| 510k Number | K951319 |
| Device Name: | ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION |
| Classification | Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Contact | Carol L Krieger |
| Correspondent | Carol L Krieger ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, 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 | 1995-03-23 |
| Decision Date | 1995-06-01 |