Cleared Traditional

Access EPO

K240182 · Beckman Coulter, Inc. · Hematology
Apr 2024
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K240182 is an FDA 510(k) clearance for the Access EPO, a Assay, Erythropoietin (Class II — Special Controls, product code GGT), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on April 22, 2024, 90 days after receiving the submission on January 23, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7250.

Submission Details

510(k) Number K240182 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2024
Decision Date April 22, 2024
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGT — Assay, Erythropoietin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7250

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