ACCESS EPO ASSAY— 510(k) K052223

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K052223 for ACCESS EPO ASSAY, Substantially Equivalent on 2006-10-06. 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: 2005-08-15
Decision date: 2006-10-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K052223

K-number listed on FDA's recall record

Z-1249-2025 — Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis) in mammals. Renal production of EPO is regulated by changes in oxygen availability. Under conditions of hypoxia, the level of EPO in the circulation increases and this leads to increased production of red blood cells.Class II·Ongoing·Beckman Coulter, Inc.·20250203

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052223.

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