510(k) K190905
K190905 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD Phoenix Automated Microbiology System GN Ceftaroline (0.0156-4 µg/mL)". The FDA issued a decision of Substantially Equivalent on Jul 1, 2019. The device falls under product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation), a Class II device regulated under 21 CFR 866.1645. Becton, Dickinson And Company has 329 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 1, 2019
- Date Received
- Apr 8, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Device Class
- Class II
- Regulation Number
- 866.1645
- Review Panel
- MI
- Submission Type
- 510(k)