ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647— 510(k) K072612

Name: FDA 510(k) clearance K072612
Creator: U.S. Food and Drug Administration
Published: 2007-10-26

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K072612 for ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647, Substantially Equivalent on 2007-10-26. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code MOI
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2007-09-17
Decision date: 2007-10-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MOI

view all

K240403 — Access BR Monitor2024-05-09
K233946 — IMMULITE® 2000 BR-MA2024-03-13
K192524 — Lumipulse G CA15-32020-09-04
K193489 — ADVIA Centaur BR2020-02-13
K192777 — ADVIA Centaur CA 15-3 assay2019-11-22

More clearances from Beckman Coulter, Inc.

view all

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

Recalls naming K072612

K-number listed on FDA's recall record

Z-2074-2017 — Access BR Monitor, Part No. 387620Class II·Terminated·Beckman Coulter Inc.·20170413

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072612.

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