Fermcotest R Bun Rate Reagent Test Kit

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K791018 ↗

FDA Product Code

CDS

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Germco Test R Glucose Test Kit

  Class II

  FDA 510(k) K810567 Active Cleared 13 Mar 1981

• Rermco Test Chloride Reagent

  Class II

  FDA 510(k) K823106 Active Cleared 16 Nov 1982

• Glucose GOD-PAP Trinder Method Test Kit

  Class II

  FDA 510(k) K791066 Active Cleared 4 Sep 1979

• Glucose Oxidase Reagent

  Class II

  FDA 510(k) K781945 Active Cleared 17 Jan 1979

• Fermcotest Creatinine Test Reagent

  Class II

  FDA 510(k) K822118 Active Cleared 30 Sep 1982

• Fermcotest CO2 Reagnet

  Class II

  FDA 510(k) K822117 Active Cleared 30 Sep 1982

See all devices from Fermco Biochemics, Inc. →