HiChem BUN Reagent

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K992847 ↗

FDA Product Code

LFP

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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

  Class II

  FDA 510(k) K992845 Active Cleared 18 Oct 1999

• 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

• Elan Alkaline Phosphate Reagent Kit

  Class II

  FDA 510(k) K991387 Active Cleared 19 May 1999

See all devices from Elan Holdings, Inc. →

• What is the intended use of the HiChem BUN Reagent?

  The HiChem BUN Reagent is an in vitro diagnostic reagent used for the quantitative determination of urea nitrogen in serum, plasma, and urine samples to assist in the diagnosis and monitoring of renal and metabolic conditions.

• Which clinical chemistry systems are compatible with this reagent?

  This reagent is specifically designed for use on Beckman Synchron CX and CX Delta clinical chemistry systems to ensure accurate chemical analysis.

• What is the regulatory status of the HiChem BUN Reagent?

  The HiChem BUN Reagent is regulated as a Class 2 medical device and received FDA 510(k) clearance under K992847.