The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Ontrak Testcup Amphetamines.
Device ID | K962411 |
510k Number | K962411 |
Device Name: | ONTRAK TESTCUP AMPHETAMINES |
Classification | Enzyme Immunoassay, Amphetamine |
Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
Contact | Maria Feijoo |
Correspondent | Maria Feijoo ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
Product Code | DKZ |
CFR Regulation Number | 862.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-21 |
Decision Date | 1996-10-07 |