COBAS-FP TDM CALIBRATION VERIFICATION TEST SET

Drug Mixture Control Materials

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas-fp Tdm Calibration Verification Test Set.

Pre-market Notification Details

Device IDK962165
510k NumberK962165
Device Name:COBAS-FP TDM CALIBRATION VERIFICATION TEST SET
ClassificationDrug Mixture Control Materials
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
ContactRita Smith
CorrespondentRita Smith
ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
Product CodeDIF  
CFR Regulation Number862.3280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-04
Decision Date1996-06-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.