The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Ontrak Testcup-er.
| Device ID | K983388 |
| 510k Number | K983388 |
| Device Name: | ONTRAK TESTCUP-ER |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| 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 | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKN |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | JXM |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-25 |
| Decision Date | 1998-11-18 |
| Summary: | summary |