510(k) Report

Devices descending from K131331

2 later devices reach BD Phoenix Automated Microbiology System - Vancomycin (0.5-32 UG/ML) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250344BD Phoenix™ Automated Microbiology SystemBecton, Dickinson and Company20250—
+1K211759Selux AST System; Model AST Gen 1.0Selux Diagnostics, Inc.20230—