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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, test,alpha-fetoprotein for testicular cancer
510(k) Number K081709
Device Name OLYMPUS AFP - ALPHA-FETOPROTEIN
Applicant
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
LISMEEHAN
O'CALLAGHANS MILLS, CO. CLARE,  IE
Applicant Contact STEPHANIE G DONNELLY
Correspondent
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
LISMEEHAN
O'CALLAGHANS MILLS, CO. CLARE,  IE
Correspondent Contact STEPHANIE G DONNELLY
Regulation Number866.6010
Classification Product Code
LOJ  
Subsequent Product Codes
JIT   JJY  
Date Received06/17/2008
Decision Date 03/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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