HICHEM GLUCOSE/HK REAGENT KIT

Hexokinase, Glucose

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Hichem Glucose/hk Reagent Kit.

Pre-market Notification Details

Device IDK960084
510k NumberK960084
Device Name:HICHEM GLUCOSE/HK REAGENT KIT
ClassificationHexokinase, Glucose
Applicant HI CHEM, INC. 231 N. PUENTE ST. Brea,  CA  92621
ContactWynn Stocking
CorrespondentWynn Stocking
HI CHEM, INC. 231 N. PUENTE ST. Brea,  CA  92621
Product CodeCFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-11
Decision Date1996-04-04
Summary:summary

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