ROCHE REAGENT FOR BUN

Urease And Glutamic Dehydrogenase, Urea Nitrogen

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 Bun.

Pre-market Notification Details

Device IDK954000
510k NumberK954000
Device Name:ROCHE REAGENT FOR BUN
ClassificationUrease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
ContactMaria Feijoo
CorrespondentMaria Feijoo
ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
Product CodeCDQ  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-25
Decision Date1995-10-25

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