Access 25(OH) Vitamin D Total— 510(k) K223503

Name: FDA 510(k) clearance K223503
Creator: U.S. Food and Drug Administration
Published: 2023-01-19

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K223503 for Access 25(OH) Vitamin D Total, Substantially Equivalent on 2023-01-19. 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: 2022-11-22
Decision date: 2023-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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K200509 — ADVIA Centaur Vitamin D Total (VitD)2020-05-29
K191499 — MAGLUMI 2000 25-OH Vitamin D2019-08-01

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