TRIGLYCERIDES - GPO REAGENT

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

ALPKEM CORP.

The following data is part of a premarket notification filed by Alpkem Corp. with the FDA for Triglycerides - Gpo Reagent.

Pre-market Notification Details

Device IDK890337
510k NumberK890337
Device Name:TRIGLYCERIDES - GPO REAGENT
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant ALPKEM CORP. BOX 1260 Clackamas,  OR  97015
ContactRaymond L Pavitt
CorrespondentRaymond L Pavitt
ALPKEM CORP. BOX 1260 Clackamas,  OR  97015
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-23
Decision Date1989-03-09

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