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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
Models KAI-115, KAI-116C
Device Name K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
Original Applicant
KAMIYA BIOMEDICAL COMPANY
12779 gateway dr
seattle,  WA  98168
Original Contact shawn kaplan
Regulation Number866.5340
Classification Product Code
DBF  
Date Received04/24/2012
Decision Date 05/24/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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