Access EPO— 510(k) K240182

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K240182 for Access EPO, Substantially Equivalent on 2024-04-22. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code GGT
Device class: Class 2
Regulation: 21 CFR 864.7250
Advisory panel: Hematology
Date received: 2024-01-23
Decision date: 2024-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGT

K183088 — ADVIA Centaur Erythropoietin (EPO) assay2019-08-02
K052223 — ACCESS EPO ASSAY2006-10-06
K992799 — SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT2000-06-07
K983203 — IMMULITE EPO, MODEL #'S LKEPZ & LKEP11999-07-12
K980737 — ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY1999-03-23

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.