GLUCOSE OXIDASE REAGENT

Glucose Oxidase, Glucose

INTERSECT SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK870616
510k NumberK870616
Device Name:GLUCOSE OXIDASE REAGENT
ClassificationGlucose Oxidase, Glucose
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 CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-12
Decision Date1987-03-06

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