The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Ontrak Testtcup Collection/urinalysis Panel.
Device ID | K964422 |
510k Number | K964422 |
Device Name: | ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL |
Classification | Drug Mixture Control Materials |
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 | DIF |
CFR Regulation Number | 862.3280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-05 |
Decision Date | 1996-11-25 |