GLUCOSE-HK REAGENT

Hexokinase, Glucose

INTERSECT SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK873835
510k NumberK873835
Device Name:GLUCOSE-HK REAGENT
ClassificationHexokinase, 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 CodeCFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-21
Decision Date1987-11-24

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