510(k) DEN160032
DEN160032 is an FDA 510(k) premarket notification submitted by Accelerate Diagnotics for the device "Accelerate Pheno system, Accelerate Phenotest BC Kit". The FDA issued a decision of De Novo Granted on February 23, 2017. The device falls under product code PRH (Positive Blood Culture Identification And Ast Kit), a Class II device regulated under 21 CFR 866.1650.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 23, 2017
- Date Received
- July 11, 2016
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Positive Blood Culture Identification And Ast Kit
- Device Class
- Class II
- Regulation Number
- 866.1650
- Review Panel
- MI
- Submission Type
Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.