FDA 510(k) Applications Submitted by STEPHANIE DONNELLY

FDA 510(k) Number Submission Date Device Name Applicant
K080094 01/14/2008 OLYMPUS TOTAL BHCG TEST SYSTEN OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
K080435 02/19/2008 OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
K081615 06/09/2008 OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN OLYMPUS AMERICA, INC.
K081709 06/17/2008 OLYMPUS AFP - ALPHA-FETOPROTEIN OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
K073487 12/12/2007 OLYMPUS IGM REAGENT OLYMPUS AMERICA INC.
K073489 12/12/2007 OLYMPUS IGA REAGENT OLYMPUS AMERICA INC.
K073490 12/12/2007 OLYMPUS IGG REAGENT OLYMPUS AMERICA INC.


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