GLUCOSE-SUPER FAST 4983050 AND 4983500

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-super Fast 4983050 And 4983500.

Pre-market Notification Details

Device IDK882262
510k NumberK882262
Device Name:GLUCOSE-SUPER FAST 4983050 AND 4983500
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 Received1988-05-31
Decision Date1989-02-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.