TRIGLYCERIDES REAGENT GPO 5 X CONC.

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

TRACE SCIENTIFIC LTD.

The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Triglycerides Reagent Gpo 5 X Conc..

Pre-market Notification Details

Device IDK903897
510k NumberK903897
Device Name:TRIGLYCERIDES REAGENT GPO 5 X CONC.
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant TRACE SCIENTIFIC LTD. P.O. BOX 310 Clayton, Australia 3168,  AU 3168
ContactPeter Murphy
CorrespondentPeter Murphy
TRACE SCIENTIFIC LTD. P.O. BOX 310 Clayton, Australia 3168,  AU 3168
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-23
Decision Date1990-10-01

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