VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS— 510(k) K121608

Clearance details

Applicant

Ortho-Clinical Diagnostics, Inc.

Product code

Code MRG

Device class

Class 2

Regulation

21 CFR 862.1825

Advisory panel

Clinical Chemistry

Date received

2012-06-01

Decision date

2013-02-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rochester, NY, US

• K232587 — MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer2024-04-12
• K221817 — ALFIS Vitamin D, ALFIS-3 Analyzer2023-09-22
• K223503 — Access 25(OH) Vitamin D Total2023-01-19
• K210901 — Elecsys Vitamin D total III2021-09-01
• K200509 — ADVIA Centaur Vitamin D Total (VitD)2020-05-29

• K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack2025-10-29
• DEN210038 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator2023-05-05
• DEN210040 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators2023-05-05
• K210858 — VITROS Chemistry Products PHBR Slides2021-08-13
• K191316 — VITROS XT Chemistry Products ALB-TP Slides2019-06-07

• Z-1193-2014 — VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems, and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH Vitamin D in human serum.Class III·Terminated·Ortho-Clinical Diagnostics·20140115

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121608.