RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)

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 Resubmitted Triglyceride Gpo Reagent (single Vial).

Pre-market Notification Details

Device IDK871509
510k NumberK871509
Device Name:RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168,  AU
ContactWilliam C Riddle
CorrespondentWilliam C Riddle
TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168,  AU
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-16
Decision Date1987-05-08

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