BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P.

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 Uv H.p..

Pre-market Notification Details

Device IDK881702
510k NumberK881702
Device Name:BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P.
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern,  PA  19355
ContactAllan C Murphy
CorrespondentAllan C Murphy
BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern,  PA  19355
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-19
Decision Date1988-05-27

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