Vitros Chemistry Products Dldl Reagent, Calibrator Kit 19, Fs Calibrator 1 and Performance Verifiers I and II

• • Terminated Z-0476-2019 FDA Class II ·initiated 8 Oct 2018

  VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results

510(k) Number

K041720 ↗

FDA Product Code

MRR

Device Class

Class I

Regulation

21 CFR Part 862.1475

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Sofia Lyme FIA

  Class II

  FDA 510(k) K254295 Active Cleared 10 Jul 2026

• Sofia 2 SARS Antigen+ FIA

  Class II

  FDA 510(k) K254264 Active Cleared 4 Sep 2026

• Sofia Influenza A+B FIA

  Class II

  FDA 510(k) K254262 Active Cleared 4 Sep 2026

• Vitros Immunodiagnostic Products Cortisol Assay

  Class II

  FDA 510(k) K983990 Active Cleared 29 Dec 1998

• Vitros Chemistry Products Caffn Reagent Kit and Tdm Performance Verifiers I, II and III

  Class II

  FDA 510(k) K042520 Active Cleared 30 Nov 2004

• Vitros Immunodiagnostic Products 25-Oh Vitamin D Total Reagent Pack, Vitamin D Total Calibrators

  Class II

  FDA 510(k) K121608 Active Cleared 15 Feb 2013

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