Fermcotest Creatinine Test Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K822118 ↗

FDA Product Code

CGX

Device Class

Class II

Regulation

21 CFR Part 862.1225

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K810567 Active Cleared 13 Mar 1981

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  FDA 510(k) K823106 Active Cleared 16 Nov 1982

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  FDA 510(k) K791066 Active Cleared 4 Sep 1979

• Glucose Oxidase Reagent

  Class II

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• Fermcotest R Bun Rate Reagent Test Kit

  Class II

  FDA 510(k) K791018 Active Cleared 17 Jul 1979

• Fermcotest CO2 Reagnet

  Class II

  FDA 510(k) K822117 Active Cleared 30 Sep 1982

See all devices from Fermco Biochemics, Inc. →