Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy Performance Verifiers

• • Terminated Z-1556-2013 FDA Class II ·initiated 1 Apr 2013

  The firm is recalling the specific lot due to lower than expected results.

510(k) Number

K061588 ↗

FDA Product Code

LPS

Device Class

Class II

Regulation

21 CFR Part 862.1377

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

See all devices from Ortho-Clinical Diagnostics, Inc. →