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

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).

Clearance details

Applicant: Olympus Life Science Research Europa GmbH (Europa)
Product code: Code LOJ
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

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