Genchem Electrolyte Buffer

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K040977 ↗

FDA Product Code

JGS

FDA applicant

Genchem, Inc.

Device Class

Class II

Regulation

21 CFR Part 862.1665

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Genchem CO2 Acid Reagent

  Class II

  FDA 510(k) K040975 Active Cleared 27 Dec 2004

• Calcium, Azo Dye Reagent

  Class II

  FDA 510(k) K040972 Active Cleared 27 Dec 2004

• Calibrator 1, 2, and 3 Models: Gen-CAL1, Gen-CAL2, and Gen-CAL3

  Class II

  FDA 510(k) K090283 Active Cleared 5 Jun 2009

• Genchem Ise Electrolyte Reference

  Class II

  FDA 510(k) K040971 Active Cleared 22 Dec 2004

• Bun Reagent

  Class II

  FDA 510(k) K040973 Active Cleared 27 Dec 2004

• Glucose Oxidase, Glucose

  Class II

  FDA 510(k) K040974 Active Cleared 27 Dec 2004

See all devices from Genchem Inc →