BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

BIOTROL, USA, INC.

The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Triglycerides Enzymatique Color.

Pre-market Notification Details

Device IDK873160
510k NumberK873160
Device Name:BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant BIOTROL, USA, INC. P.O. BOX 562 Berwyn,  PA  19312
ContactAllan C Murphy
CorrespondentAllan C Murphy
BIOTROL, USA, INC. P.O. BOX 562 Berwyn,  PA  19312
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-11
Decision Date1987-09-08

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