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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 hsv-1 and hsv-2 cns nucleic-acid based panel
De Novo Number DEN130049
510(K) Number K133621
Device Name SIMPLEXA HSV 1&2 DIRECT
Requester
focus diagnostics
11331 valley view street
cypress,  CA  90630
Contact sharon young
Regulation Number866.3307
Classification Product Code
PGH  
Date Received11/25/2013
Decision Date 03/21/2014
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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