GLUCOSE OXIDASE REAGENT SET

Glucose Oxidase, Glucose

TECHNOSTICS INTL.

The following data is part of a premarket notification filed by Technostics Intl. with the FDA for Glucose Oxidase Reagent Set.

Pre-market Notification Details

Device IDK855194
510k NumberK855194
Device Name:GLUCOSE OXIDASE REAGENT SET
ClassificationGlucose Oxidase, Glucose
Applicant TECHNOSTICS INTL. P.O. BOX 94090 Washington,  MI  48094
ContactSusan Renehan
CorrespondentSusan Renehan
TECHNOSTICS INTL. P.O. BOX 94090 Washington,  MI  48094
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-26
Decision Date1986-01-14

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