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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 positive blood culture identification and ast kit
De Novo Number DEN160032
Device Name Accelerate Pheno system, Accelerate Phenotest BC Kit
Requester
accelerate diagnotics
3950 s. country club rd. #470
tucson,  AZ  85714
Contact maureen mende
Regulation Number866.1650
Classification Product Code
PRH  
Date Received07/11/2016
Decision Date 02/23/2017
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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