The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Abuscreen Online For Cannabinoids (1000 Test Kit).
| Device ID | K981585 |
| 510k Number | K981585 |
| Device Name: | ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Contact | Rita Smith |
| Correspondent | Rita Smith ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-04 |
| Decision Date | 1998-05-28 |