GLUCOSE LIQUID AMRESCO #4628300 & 4628001L

Glucose Oxidase, Glucose

AMERICAN RESEARCH PRODUCTS CO.

The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Glucose Liquid Amresco #4628300 & 4628001l.

Pre-market Notification Details

Device IDK884909
510k NumberK884909
Device Name:GLUCOSE LIQUID AMRESCO #4628300 & 4628001L
ClassificationGlucose Oxidase, Glucose
Applicant AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon,  OH  44139
ContactDianne Eich
CorrespondentDianne Eich
AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon,  OH  44139
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-23
Decision Date1989-01-03

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