ROCHE AMMONIA (VARIOUS)

Calibrators, Drug Mixture

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Ammonia (various).

Pre-market Notification Details

Device IDK942048
510k NumberK942048
Device Name:ROCHE AMMONIA (VARIOUS)
ClassificationCalibrators, Drug Mixture
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
ContactCarol L Krieger
CorrespondentCarol L Krieger
ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
Product CodeDKB  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-28
Decision Date1994-10-04

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