ATAC Direct Bilirubin Reagent and Calibrator

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

510(k) Number

K030003 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Atac Calcium Reagent and Atac Calibrator

  Class II

  FDA 510(k) K023105 Active Cleared 13 Mar 2003

• Atac Calibrator

  Class II

  FDA 510(k) K030621 Active Cleared 19 Mar 2003

• Atac Pak Albumin Reagent

  Class II

  FDA 510(k) K030006 Active Cleared 7 Mar 2003

• Atac Direct Ldl Reagent and Atac Direct Ldl Calibrator Kits

  Class I

  FDA 510(k) K020575 Active Cleared 12 Apr 2002

• Atac Pak Bun Reagent

  Class II

  FDA 510(k) K021385 Active Cleared 12 Jul 2002

• Atac Pak Phosphorus Reagent

  Class I

  FDA 510(k) K030015 Active Cleared 7 Mar 2003

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• What is the ATAC Direct Bilirubin Reagent and Calibrator used for?

  It is used for the quantitative determination of conjugated bilirubin in serum and plasma samples through a chemical reaction with diazotized sulfanilic acid that forms a red-purple complex measured photometrically.

• What system is the ATAC Direct Bilirubin Reagent and Calibrator intended for use with?

  It is intended for use with the ATAC 8000 Random Access Chemistry System, as a reagent and calibrator combination for clinical chemistry testing.

• Is the ATAC Direct Bilirubin Reagent and Calibrator supplied as a single reagent or a kit?

  It is supplied as a reagent and calibrator combination kit, designed for use together in clinical chemistry testing on the ATAC 8000 system.

• What regulatory pathway was used for the ATAC Direct Bilirubin Reagent and Calibrator?

  The device received FDA 510(k) clearance under K030003 and is classified as a Class II device under regulation number 862.1110.