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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 dengue serological reagents
De Novo Number DEN100020
510(K) Number K100534
Device Name DENV DETECT IGM CAPTURE ELISA
Requester
inbios intl., inc.
562 1st. ave. south, suite 600
seattle,  WA  98104
Contact estela i raychaudhuri
Regulation Number866.3945
Classification Product Code
OSU  
Date Received10/20/2010
Decision Date 04/08/2011
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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