Atac Pak Uric Acid Reagent and Atac Calibrator

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

510(k) Number

K031044 ↗

FDA Product Code

KNK

Device Class

Class I

Regulation

21 CFR Part 862.1775

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• In-Vitro Test Determination Total Bilirubin

  Class II

  FDA 510(k) K854180 Active Cleared 25 Nov 1985

• Centurion-II, Model 3103 Apnea/Brady Cardia Trachy

  Class II

  FDA 510(k) K851889 Active Cleared 23 Oct 1985

• Vitalab Uric Acid Reagent

  Class I

  FDA 510(k) K040467 Active Cleared 8 Mar 2004

• Envoy 500 Hdl; Cholesterol Reagent Kit (Model# 55301), Calibrator Kit (Model# 55118)

  Class I

  FDA 510(k) K071706 Active Cleared 20 Dec 2007

• Full-Disclosure Ambulatory ECG System

  Class II

  FDA 510(k) K823529 Active Cleared 15 Dec 1982

• Vitalab Direct Bilirubin Reagent

  Class II

  FDA 510(k) K040631 Active Cleared 18 Mar 2004

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