FDA.reportPublic FDA data

De Novo DEN160032

Device
Accelerate Pheno system, Accelerate Phenotest BC Kit
Contact
maureen mende
De Novo number
DEN160032
Product code
PRH
Regulation
866.1650
Classification name
positive blood culture identification and ast kit
Decision
granted (DENG)
Decision date
2017-02-23
Date received
2016-07-11
Classification advisory
Microbiology
Review advisory
Microbiology
Type
Direct

Current FDA Classification#

Product code
PRH
Device name
Positive Blood Culture Identification And Ast Kit
Medical specialty
Microbiology
Device class
2
Regulation
866.1650
Implant
N
Life sustain/support
N