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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 test, alpha fetoprotein l3 subfraction (afp-l3%), for hepatocellular carcinoma risk assessment
De Novo Number DEN050002
510(K) Number K041847
Device Name LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
Requester
wako chemicals, usa, inc.
1600 bellwood road
richmond,  VA  23237
Contact tonya mallory
Regulation Number866.6030
Classification Product Code
NSF  
Date Received04/07/2005
Decision Date 05/19/2005
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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