MULTICHEM CREATININE REAGENT S0917

Alkaline Picrate, Colorimetry, Creatinine

SIMMLER, INC.

The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Multichem Creatinine Reagent S0917.

Pre-market Notification Details

Device IDK873725
510k NumberK873725
Device Name:MULTICHEM CREATININE REAGENT S0917
ClassificationAlkaline Picrate, Colorimetry, Creatinine
Applicant SIMMLER, INC. POST OFFICE BOX 25179 St. Louis,  MO  63125
ContactQuincy E Crider,phd
CorrespondentQuincy E Crider,phd
SIMMLER, INC. POST OFFICE BOX 25179 St. Louis,  MO  63125
Product CodeCGX  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-15
Decision Date1987-10-20

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