510(k) Report

Devices descending from DEN150013

3 later devices reach FilmArray Meningitis/Encephalitis (ME) Panel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160462FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray TorchBiofire Diagnostics, LLC20162—
+2K242256QIAstat-Dx Meningitis/Encephalitis (ME) PanelQIAGEN GmbH20240—
+2K190219Simplexa VZV Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC201901