TRIGLYCERIDE REAGENT SET

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

OMEGA MEDICAL ELECTRONICS

The following data is part of a premarket notification filed by Omega Medical Electronics with the FDA for Triglyceride Reagent Set.

Pre-market Notification Details

Device IDK821205
510k NumberK821205
Device Name:TRIGLYCERIDE REAGENT SET
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant OMEGA MEDICAL ELECTRONICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-04-27
Decision Date1982-07-20

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