CREATININE (RATE) REAGENT SET

Alkaline Picrate, Colorimetry, Creatinine

BIOCHEMICAL TRADE, INC.

The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Creatinine (rate) Reagent Set.

Pre-market Notification Details

Device IDK905619
510k NumberK905619
Device Name:CREATININE (RATE) REAGENT SET
ClassificationAlkaline Picrate, Colorimetry, Creatinine
Applicant BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami,  FL  33166
ContactAlejo Roy
CorrespondentAlejo Roy
BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami,  FL  33166
Product CodeCGX  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-14
Decision Date1991-02-13

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