TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

CATACHEM, INC.

The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Triglycerides For Continuous Flow Instruments.

Pre-market Notification Details

Device IDK860690
510k NumberK860690
Device Name:TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant CATACHEM, INC. 6 NORTH PEARL ST. Port Chester,  NY  10573
ContactLuis P Leon
CorrespondentLuis P Leon
CATACHEM, INC. 6 NORTH PEARL ST. Port Chester,  NY  10573
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-25
Decision Date1986-03-17

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