The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Abuscreen Ontrak Pos. Ref. Control-methadone.
Device ID | K930844 |
510k Number | K930844 |
Device Name: | ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE |
Classification | Drug Specific Control Materials |
Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
Contact | Carol L Krieger |
Correspondent | Carol L Krieger ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
Product Code | LAS |
CFR Regulation Number | 862.3280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-18 |
Decision Date | 1994-01-27 |