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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 meprobamate test system
De Novo Number DEN170010
Device Name LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
Requester
lin-zhi international, inc.
2945 oakmead village court
santa clara,  CA  95051
Contact chris wang
Regulation Number862.3590
Classification Product Code
QBK  
Date Received02/21/2017
Decision Date 04/20/2018
Decision granted (DENG)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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