KING DIAGNOSTICS GLUCOSE (HK) REAGENT

Hexokinase, Glucose

KING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for King Diagnostics Glucose (hk) Reagent.

Pre-market Notification Details

Device IDK923129
510k NumberK923129
Device Name:KING DIAGNOSTICS GLUCOSE (HK) REAGENT
ClassificationHexokinase, Glucose
Applicant KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis,  IN  46220
ContactFrances Loh
CorrespondentFrances Loh
KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis,  IN  46220
Product CodeCFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-26
Decision Date1992-11-02

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