Access Rubella IgG— 510(k) K250588

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K250588 for Access Rubella IgG, Substantially Equivalent on 2025-11-17. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 2025-02-27
Decision date: 2025-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFX

K243168 — Alinity i Rubella IgG2025-06-20
K122397 — LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM2012-09-06
K093101 — MAGO 4S2011-01-21
K092587 — BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM2010-12-03
K092322 — ELECSYS RUBELLA IGM IMMUNOASSAY2010-03-12

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
K252580 — iQ200 Series2025-09-10

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