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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 K053211
Device Name RDI HSFERRITIN KIT
Applicant
REFERENCE DIAGNOSTICS, INC.
19 CROSBY DR. SUITE 30
BEDFORD,  MA  01730
Applicant Contact JOSEPH LAWLOR
Correspondent
REFERENCE DIAGNOSTICS, INC.
19 CROSBY DR. SUITE 30
BEDFORD,  MA  01730
Correspondent Contact JOSEPH LAWLOR
Regulation Number866.5340
Classification Product Code
DBF  
Date Received11/16/2005
Decision Date 03/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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