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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 K121232
Device Name K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
Applicant
Kamiya Biomedical Company
12779 Gateway Dr.
Tukwila,  WA  98168
Applicant Contact SHAWN KAPLAN
Correspondent
Kamiya Biomedical Company
12779 Gateway Dr.
Tukwila,  WA  98168
Correspondent Contact SHAWN KAPLAN
Regulation Number866.5340
Classification Product Code
DBF  
Date Received04/24/2012
Decision Date 05/24/2012
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
Predetermined Change
Control Plan Authorized		 No
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