ROCHE REAGENT FOR CREATININE

Alkaline Picrate, Colorimetry, Creatinine

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Reagent For Creatinine.

Pre-market Notification Details

Device IDK941837
510k NumberK941837
Device Name:ROCHE REAGENT FOR CREATININE
ClassificationAlkaline Picrate, Colorimetry, Creatinine
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 CodeCGX  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-13
Decision Date1994-08-26

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