ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET

Nad Reduction/nadh Oxidation, Lactate Dehydrogenase

BIOCHEMICAL TRADE, INC.

The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Ultraviolet Lactate Dehydrogenase Reagent Set.

Pre-market Notification Details

Device IDK871781
510k NumberK871781
Device Name:ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET
ClassificationNad Reduction/nadh Oxidation, Lactate Dehydrogenase
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 CodeCFJ  
CFR Regulation Number862.1440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-06
Decision Date1987-06-03

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