510(k) Report

Devices descending from K160462

2 later devices reach FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242256QIAstat-Dx Meningitis/Encephalitis (ME) PanelQIAGEN GmbH20240—
+1K190219Simplexa VZV Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC201901