Glucose Oxidase Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K781945 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Fermcotest Creatinine Test Reagent

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• Fermcotest CO2 Reagnet

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See all devices from Fermco Biochemics, Inc. →