RAICHEM CREATININE REAGENT

Alkaline Picrate, Colorimetry, Creatinine

REAGENTS APPLICATIONS, INC.

The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem Creatinine Reagent.

Pre-market Notification Details

Device IDK840872
510k NumberK840872
Device Name:RAICHEM CREATININE REAGENT
ClassificationAlkaline Picrate, Colorimetry, Creatinine
Applicant REAGENTS APPLICATIONS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGX  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-27
Decision Date1984-04-18

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