Atac Pak Ast Reagent Kit

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

510(k) Number

K010488 ↗

FDA Product Code

CIT

Device Class

Class II

Regulation

21 CFR Part 862.1100

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

• HiChem BUN Reagent

  Class II

  FDA 510(k) K992847 Active Cleared 14 Oct 1999

See all devices from Elan Holdings, Inc. →

• What is the ATAC PAK AST REAGENT KIT used for?

  The ATAC PAK AST REAGENT KIT is a clinical chemistry device used for the determination of AST (aspartate aminotransferase) in human serum or plasma. It operates based on the NADH oxidation/NAD reduction principle for measuring enzyme activity levels.

• How is the ATAC PAK AST REAGENT KIT supplied and is it reusable?

  The device is supplied as a reagent kit and is intended for single-use in clinical laboratory settings. It is not MRI compatible and requires appropriate storage conditions to maintain its effectiveness.

• What is the regulatory classification of the ATAC PAK AST REAGENT KIT?

  The device has FDA 510(k) clearance with product code CIT and is classified as Class II medical device for clinical chemistry applications. It was cleared through the traditional 510(k) process and is substantially equivalent to predicate devices.

• What are the storage requirements for the ATAC PAK AST REAGENT KIT?

  The device requires appropriate storage conditions to maintain its integrity and effectiveness. However, specific temperature ranges or storage durations are not provided in the available information.