GLUCOSE DETERM. KIT

Glucose Oxidase, Glucose

ANALYTICAL & RESEARCH CHEMICALS, INC.

The following data is part of a premarket notification filed by Analytical & Research Chemicals, Inc. with the FDA for Glucose Determ. Kit.

Pre-market Notification Details

Device IDK781307
510k NumberK781307
Device Name:GLUCOSE DETERM. KIT
ClassificationGlucose Oxidase, Glucose
Applicant ANALYTICAL & RESEARCH CHEMICALS, 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 Received1978-07-28
Decision Date1978-08-31

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