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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 norovirus serological reagent
De Novo Number DEN110001
510(K) Number K093295
Device Name RIDASCREEN NOROVIRUS 3RD GENERATION EIA
Requester
r-biopharm ag
150 cherry lane rd.
east stroudsburg,  PA  18301
Contact gary lehnus
Regulation Number866.3395
Classification Product Code
OUC  
Date Received02/16/2011
Decision Date 02/23/2011
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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