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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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De Novo Number DEN160032
Device Name Accelerate Pheno system, Accelerate Phenotest BC Kit
Requester
ACCELERATE DIAGNOTICS
3950 s. country club road #470
tucson,  AZ  85714
Contact maureen mende
Classification Product Code
PRH
Date Received07/11/2016
Decision Date 02/23/2017
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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