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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name method, nephelometric, immunoglobulins (g, a, m)
510(k) Number K073489
Device Name OLYMPUS IGA REAGENT
Applicant
OLYMPUS AMERICA INC.
LISMEEHAN, O, CALLAGHAN'S
MILLS
CO. CLARE,  IE
Applicant Contact STEPHANIE G DONNELLY
Correspondent
OLYMPUS AMERICA INC.
LISMEEHAN, O, CALLAGHAN'S
MILLS
CO. CLARE,  IE
Correspondent Contact STEPHANIE G DONNELLY
Regulation Number866.5510
Classification Product Code
CFN  
Date Received12/12/2007
Decision Date 02/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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