Access Ferritin— 510(k) K234052

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K234052 for Access Ferritin, Substantially Equivalent on 2024-03-20. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JMG
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 2023-12-21
Decision date: 2024-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JMG

K052082 — FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 330202005-08-19
K964282 — TINA-QUANT FERRITIN ASSAY1997-07-30
K971833 — ELECSYS FERRITIN1997-06-02
K963498 — FERR FLEX REAGENT CARTRIDGE1997-01-24
K950393 — ACE(TM) CEDIA(R) FERRITIN ASSAY1995-05-16

More clearances from Beckman Coulter, Inc.

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.