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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 K062746
Device Name FERRITIN-LATEX, MODELS 1418-2070, 1418-0279
Applicant
MEDICON HELLAS S.A.
5-7 MELITONA ST.
GERAKAS, ATTIKI,  GR 15344
Applicant Contact GEORGE PSICHAS
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number866.5340
Classification Product Code
DBF  
Date Received09/14/2006
Decision Date 11/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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