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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ferritin, antigen, antiserum, control
510(k) Number K030124
Device Name OLYMPUS FERRITIN REAGENT
Applicant
OLYMPUS AMERICA, INC.
3131 WEST ROYAL LN.
IRVING,  TX  75063 -3104
Applicant Contact MICHAEL CAMPBELL
Correspondent
OLYMPUS AMERICA, INC.
3131 WEST ROYAL LN.
IRVING,  TX  75063 -3104
Correspondent Contact MICHAEL CAMPBELL
Regulation Number866.5340
Classification Product Code
DBF  
Date Received01/14/2003
Decision Date 02/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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