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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 K050944
Device Name K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
Applicant
Kamiya Biomedical Co.
12779 Gateway Dr.
Tukwila,  WA  98168
Applicant Contact BRIAN SCHLIESMAN
Correspondent
Kamiya Biomedical Co.
12779 Gateway Dr.
Tukwila,  WA  98168
Correspondent Contact BRIAN SCHLIESMAN
Regulation Number866.5340
Classification Product Code
DBF  
Subsequent Product Code
JIT  
Date Received04/14/2005
Decision Date 12/23/2005
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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