510(k) K181665

BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN by Becton, Dickinson And Company — Product Code LON

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)