510(k) Report

Devices descending from K123404

1 later device reach BD Phoenix Automated Microbiology System- Imipenem (0.0625-32 UG/ML) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and Company20250—