INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

INTERSECT SYSTEMS, INC.

The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Intersect Systems Triglyceride-gpo Reagent.

Pre-market Notification Details

Device IDK870827
510k NumberK870827
Device Name:INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant INTERSECT SYSTEMS, INC. 1606 E. KESSLER BLVD., #100 P.O. BOX 889 Longview,  WA  98632
ContactLester B Garrison
CorrespondentLester B Garrison
INTERSECT SYSTEMS, INC. 1606 E. KESSLER BLVD., #100 P.O. BOX 889 Longview,  WA  98632
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-03
Decision Date1987-03-13

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