The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Ontrak Testcup 5 (modification).
| Device ID | K964355 |
| 510k Number | K964355 |
| Device Name: | ONTRAK TESTCUP 5 (MODIFICATION) |
| Classification | Enzyme Immunoassay, Phencyclidine |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Contact | Alex Wesolowski |
| Correspondent | Alex Wesolowski ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Product Code | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-01 |
| Decision Date | 1996-12-13 |