510(k) K181665
K181665 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN". The FDA issued a decision of Substantially Equivalent on Sep 21, 2018. 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
- Sep 21, 2018
- Date Received
- Jun 25, 2018
- 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)