Creatine Kinase Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K803301 ↗

FDA Product Code

CGS

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Cesium Diluent 7.5M

  Class II

  FDA 510(k) K811886 Active Cleared 23 Jul 1981

• Albumin Reagent

  Class II

  FDA 510(k) K781773 Active Cleared 22 Nov 1978

• Blood Sugar

  Class II

  FDA 510(k) K781783 Active Cleared 4 Dec 1978

• Uric Acid Standard

  Class II

  FDA 510(k) K792046 Active Cleared 30 Oct 1979

• Gilchem Calcium Reagent

  Class II

  FDA 510(k) K812110 Active Cleared 13 Aug 1981

• Alt Reagent

  Class I

  FDA 510(k) K800038 Active Cleared 21 Jan 1980

See all devices from Gilford Diagnostics →