COLORIMETRIC URIC ACID REAGENT SET

Acid, Uric, Uricase (colorimetric)

BIOCHEMICAL TRADE, INC.

The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Colorimetric Uric Acid Reagent Set.

Pre-market Notification Details

Device IDK871417
510k NumberK871417
Device Name:COLORIMETRIC URIC ACID REAGENT SET
ClassificationAcid, Uric, Uricase (colorimetric)
Applicant BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami,  FL  33152
ContactRoy, Ph.d.
CorrespondentRoy, Ph.d.
BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami,  FL  33152
Product CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-07
Decision Date1987-04-22

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