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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 plasmodium spp. detection reagents
De Novo Number DEN070006
510(K) Number K061542
Device Name BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX
Requester
inverness medical professional diagnostics-binax
10 southgate rd.
scarborough,  ME  04074
Contact anne jepson
Regulation Number866.3402
Classification Product Code
OAX  
Date Received03/23/2007
Decision Date 06/13/2007
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
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