510(k) Report

Devices descending from K123274

4 later devices reach Progastro SSCS Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140111BD Max (TM) Enteric Bacterial Panel;BD Max (TM) InstrumentBecton, Dickinson and Company201432
+2K250358BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR…Becton, Dickinson and Company20250—
+2K214122BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial PanelBecton, Dickinson and Company20221—
+2K173330PanNAT STEC TestMicronics, Inc.20180—