Hichem Calibrator 1 Kit, Hichem Calibrator 2 Kit, Hichem Calibrator 3 Kit, Calibration Standards Kit

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

510(k) Number

K992845 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Hichem Total Protein Reagent

  Class II

  FDA 510(k) K992846 Active Cleared 18 Oct 1999

• Hichem Ise Electrolyte Reference

  Class II

  FDA 510(k) K992842 Active Cleared 26 Nov 1999

• Atac-Pak Direct Hdl Cholesterol Reagent and Atac Hdl-C Calibrator Kits

  Class I

  FDA 510(k) K991789 Active Cleared 9 Jul 1999

• Atac Pak Bun Reagent and Atac Calibrator Kits

  Class II

  FDA 510(k) K000958 Active Cleared 24 May 2000

• HiChem BUN Reagent

  Class II

  FDA 510(k) K992847 Active Cleared 14 Oct 1999

• Elan Alkaline Phosphate Reagent Kit

  Class II

  FDA 510(k) K991387 Active Cleared 19 May 1999

See all devices from Elan Holdings, Inc. →