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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 east 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
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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