TRIGLYCERIDES DETERMINATION

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

BIOCHEMICAL TRADE, INC.

The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Triglycerides Determination.

Pre-market Notification Details

Device IDK871122
510k NumberK871122
Device Name:TRIGLYCERIDES DETERMINATION
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami,  FL  33152
ContactAlejo V Roy
CorrespondentAlejo V Roy
BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami,  FL  33152
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-20
Decision Date1987-04-07

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