Cleared Traditional

Access CEA

K223921 · Beckman Coulter, Inc. · Immunology
Sep 2023
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K223921 is an FDA 510(k) clearance for the Access CEA, a System, Test, Carcinoembryonic Antigen (Class II — Special Controls, product code DHX), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on September 22, 2023, 267 days after receiving the submission on December 29, 2022. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K223921 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2022
Decision Date September 22, 2023
Days to Decision 267 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHX — System, Test, Carcinoembryonic Antigen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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