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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name zinc transporter 8 auto-antibody
De Novo Number DEN140001
Device Name ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
Requester
kronus market development associates, inc.
170 s. seneca springs way
suite 105
star,  ID  83669
Contact tanis jimenez
Regulation Number866.5670
Classification Product Code
PHF  
Date Received06/16/2014
Decision Date 08/20/2014
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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