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FDA 510(k) Applications Submitted by STEPHANIE G 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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