ROCHE COBAS READY RENAL PROFILE REAGENT STRIP

O-phthalaldehyde, 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 Cobas Ready Renal Profile Reagent Strip.

Pre-market Notification Details

Device IDK904049
510k NumberK904049
Device Name:ROCHE COBAS READY RENAL PROFILE REAGENT STRIP
ClassificationO-phthalaldehyde, Urea Nitrogen
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. ONE SUNSET AVE. Montclair,  NJ  07042
ContactCarol Krieger
CorrespondentCarol Krieger
ROCHE DIAGNOSTIC SYSTEMS, INC. ONE SUNSET AVE. Montclair,  NJ  07042
Product CodeJGZ  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-04
Decision Date1990-10-12

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