LIPASE HYDROLYSIS/GLYCEROL KINASE

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

POINTE SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Lipase Hydrolysis/glycerol Kinase.

Pre-market Notification Details

Device IDK832871
510k NumberK832871
Device Name:LIPASE HYDROLYSIS/GLYCEROL KINASE
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant POINTE SCIENTIFIC, INC. 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 Received1983-08-25
Decision Date1983-10-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.