510(k) K192665
K192665 is an FDA 510(k) premarket notification submitted by Accelerate Diagnostics, Inc. for the device "Accelerate Pheno System, Accelerate PhenoTest BC Kit". The FDA issued a decision of Substantially Equivalent on September 15, 2020. The device falls under product code PRH (Positive Blood Culture Identification And Ast Kit), a Class II device regulated under 21 CFR 866.1650. Accelerate Diagnostics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 15, 2020
- Date Received
- September 25, 2019
- Clearance Type
- Traditional
- 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.