TRIGLYCERIDES-E

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

J. D. ASSOC.

The following data is part of a premarket notification filed by J. D. Assoc. with the FDA for Triglycerides-e.

Pre-market Notification Details

Device IDK863075
510k NumberK863075
Device Name:TRIGLYCERIDES-E
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant J. D. ASSOC. 163 MONTCLAIR AVE. Montclair,  NJ  07042
ContactDi Pietro
CorrespondentDi Pietro
J. D. ASSOC. 163 MONTCLAIR AVE. Montclair,  NJ  07042
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-12
Decision Date1986-09-26

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