Cleared Abbreviated

ACCESS EPO ASSAY

K052223 · Beckman Coulter, Inc. · Hematology
Oct 2006
Decision
417d
Days
Class 2
Risk

About This 510(k) Submission

K052223 is an FDA 510(k) clearance for the ACCESS EPO ASSAY, a Assay, Erythropoietin (Class II — Special Controls, product code GGT), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on October 6, 2006, 417 days after receiving the submission on August 15, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7250.

Submission Details

510(k) Number K052223 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2005
Decision Date October 06, 2006
Days to Decision 417 days
Submission Type Abbreviated
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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