ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS— 510(k) K031270

Name: FDA 510(k) clearance K031270
Creator: U.S. Food and Drug Administration
Published: 2003-05-06

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K031270 for ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, Substantially Equivalent on 2003-05-06. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code DHX
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2003-04-21
Decision date: 2003-05-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DHX

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K223921 — Access CEA2023-09-22
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K200215 — ADVIA Centaur CEA Assay2020-04-13
K081615 — OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN2009-03-18
K080194 — VIDAS CEA (S) ASSAY2008-10-09

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Recalls naming K031270

K-number listed on FDA's recall record

Z-0239-2016 — Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.Class II·Terminated·Beckman Coulter Inc.·20151013

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031270.

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