510(k) Report

Devices descending from K182619

2 later devices reach ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262168QIAstat-Dx BCID GN Plus AMR PanelQIAGEN GmbH20260—
+1K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated20220—