The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Ontrak Testcup Collection/urinalysis Panel For Cocaine, Morphine And Thc.
| Device ID | K944231 |
| 510k Number | K944231 |
| Device Name: | ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Contact | Carol Krieger |
| Correspondent | Carol Krieger ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-31 |
| Decision Date | 1994-12-02 |