ELECTROLYTE GEL

Glucose Oxidase, Glucose

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Electrolyte Gel.

Pre-market Notification Details

Device IDK813370
510k NumberK813370
Device Name:ELECTROLYTE GEL
ClassificationGlucose Oxidase, Glucose
Applicant HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-30
Decision Date1981-12-22

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