OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN— 510(k) K081615

Name: FDA 510(k) clearance K081615
Creator: U.S. Food and Drug Administration
Published: 2009-03-18

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K081615 for OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN, Substantially Equivalent on 2009-03-18. Applicant: Olympus America, Inc.. Device class: 2.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code DHX
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2008-06-09
Decision date: 2009-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Co. Clare, IE

Download summary PDF View on FDA.gov ↗

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