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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 groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system
De Novo Number DEN140005
510(K) Number K133883
Device Name LYRA DIRECT STREP ASSAY
Requester
quidel corporation
2005 e. state st., suite# 100
athens,  OH  45701
Contact ronald h lollar
Regulation Number866.2680
Classification Product Code
PGX  
Date Received03/25/2014
Decision Date 04/16/2014
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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