Vitros Immunodiagnostic Products Folate Verifiers, Vitros Immunodiagnostic Products Vitamin B12 Range Verifiers

No FDA recalls found in the data synced 23 Oct 2026.

510(k) Number

K990026 ↗

FDA Product Code

JJX

Device Class

Class I

Regulation

21 CFR Part 862.1660

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. →