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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 plazomicin test system, immunoassay
De Novo Number DEN180030
Device Name QMS Plazomicin Immunoassay
Requester
microgenics corporation
46500 kato rd.
fremond,  CA  94538
Contact minoti patel
Regulation Number862.3460
Classification Product Code
QDR  
Date Received06/25/2018
Decision Date 11/19/2018
Decision granted (DENG)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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