REAGENT FOR DETERM. GLUCOSE IN H/SERUM

Glucose Oxidase, Glucose

DIAGNOSTIC SOLUTIONS, INC.

The following data is part of a premarket notification filed by Diagnostic Solutions, Inc. with the FDA for Reagent For Determ. Glucose In H/serum.

Pre-market Notification Details

Device IDK800687
510k NumberK800687
Device Name:REAGENT FOR DETERM. GLUCOSE IN H/SERUM
ClassificationGlucose Oxidase, Glucose
Applicant DIAGNOSTIC SOLUTIONS, 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 Received1980-03-26
Decision Date1980-05-28

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