Cleared Traditional

OLYMPUS AFP - ALPHA-FETOPROTEIN

K081709 · Olympus Life Science Research Europa GmbH (Europa) · Immunology

Mar 2009

Decision

272d

Days

Class 2

Risk

About This 510(k) Submission

K081709 is an FDA 510(k) clearance for the OLYMPUS AFP - ALPHA-FETOPROTEIN, a Kit, Test,alpha-fetoprotein For Testicular Cancer (Class II — Special Controls, product code LOJ), submitted by Olympus Life Science Research Europa GmbH (Europa) (O'Callaghans Mills, Co. Clare, IE). The FDA issued a Cleared decision on March 16, 2009, 272 days after receiving the submission on June 17, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K081709 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2008
Decision Date	March 16, 2009
Days to Decision	272 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement