OLYMPUS AFP - ALPHA-FETOPROTEIN— 510(k) K081709

Name: FDA 510(k) clearance K081709
Creator: U.S. Food and Drug Administration
Published: 2009-03-16

Substantially Equivalent

Olympus Life Science Research Europa GmbH (Europa)

FDA 510(k) clearance K081709 for OLYMPUS AFP - ALPHA-FETOPROTEIN, Substantially Equivalent on 2009-03-16. Applicant: Olympus Life Science Research Europa GmbH (Europa). Device class: 2.

Clearance details

Applicant: Olympus Life Science Research Europa GmbH (Europa)
Product code: Code LOJ
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2008-06-17
Decision date: 2009-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: O'Callaghans Mills, Co. Clare, IE

Download summary PDF View on FDA.gov ↗

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