GLUCOSE REAGENT KITS-B6370-10A

Glucose Oxidase, Glucose

AMERICAN SCIENTIFIC PRODUCTS

The following data is part of a premarket notification filed by American Scientific Products with the FDA for Glucose Reagent Kits-b6370-10a.

Pre-market Notification Details

Device IDK831624
510k NumberK831624
Device Name:GLUCOSE REAGENT KITS-B6370-10A
ClassificationGlucose Oxidase, Glucose
Applicant AMERICAN SCIENTIFIC PRODUCTS 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 Received1983-05-20
Decision Date1983-07-06

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