510(k) Report

Devices descending from K190905

1 later device reach BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211748Selux AST System; Model AST Gen 1.0Selux Diagnostics, Inc.20230—