LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

ELECTRO-NUCLEONICS LABORATORIES, INC.

The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Lipase Hydrolysis/glycerol Kinase, Triglycerides.

Pre-market Notification Details

Device IDK863874
510k NumberK863874
Device Name:LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046
ContactLabrec, Ph.d.
CorrespondentLabrec, Ph.d.
ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-03
Decision Date1986-11-13

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