Access anti-HAV IgM— 510(k) K251995

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K251995 for Access anti-HAV IgM, Substantially Equivalent on 2026-01-27. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LOL
Device class: Class 2
Regulation: 21 CFR 866.3310
Advisory panel: Microbiology
Date received: 2025-06-27
Decision date: 2026-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LOL

K260048 — Elecsys Anti-HAV IgM2026-04-07
K243846 — Access anti-HAV2025-09-09
K222850 — HAVAb IgG II2023-08-10
K223403 — LIAISON Anti-HAV; LIAISON XS2022-12-09
K210272 — LIAISON Anti-HAV2021-02-09

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
K250588 — Access Rubella IgG2025-11-17
K252580 — iQ200 Series2025-09-10

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