Access MeMed BV— 510(k) K261109

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K261109 for Access MeMed BV, Substantially Equivalent on 2026-10-19. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Product code QPS
Device class: Class 2
Regulation: 21 CFR 866.3215
Advisory panel: Microbiology
Date received: 2026-04-03
Decision date: 2026-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QPS

K230944 — MeMed BV2023-06-30
K222332 — MeMed BV2023-03-23
K213936 — LIAISON MeMed BV, LIAISON MeMed BV Control Set2022-07-14
K210254 — MeMed BV2021-09-01

More clearances from Beckman Coulter, Inc.

K262597 — Access BNP II2026-10-20
K262109 — Access NT-proBNP2026-09-21
K252169 — Access BNP II2026-03-24
K254059 — Access anti-HBc IgM2026-03-13
K253687 — Access anti-HBc Total2026-02-19

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