Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst— 510(k) K142373

Name: FDA 510(k) clearance K142373
Creator: U.S. Food and Drug Administration
Published: 2014-12-22

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K142373 for Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst, Substantially Equivalent on 2014-12-22. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code MRG
Device class: Class 2
Regulation: 21 CFR 862.1825
Advisory panel: Clinical Chemistry
Date received: 2014-08-25
Decision date: 2014-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MRG

view all

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

More clearances from Beckman Coulter, Inc.

view all

K252169 — Access BNP II2026-03-24
K254059 — Access anti-HBc IgM2026-03-13
K253687 — Access anti-HBc Total2026-02-19
K251995 — Access anti-HAV IgM2026-01-27
K250588 — Access Rubella IgG2025-11-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.