510(k) K173252
K173252 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)". The FDA issued a decision of Substantially Equivalent on Jan 5, 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
- Jan 5, 2018
- Date Received
- Oct 10, 2017
- 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)