510(k) Report

Devices descending from K190222

8 later devices reach FilmArray Pneumonia/Pneumoniaplus Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200010FilmArray BCID2 Control Panel M416Maine Molecular Quality Controls, Inc.20207—
+2K203680BioFire JI Control Panel M420Maine Molecular Quality Controls, Inc.20220—
+2K212576MDx-Chex for BCID2Streck, Inc.20225—
+3K254167MDx-Chex for BCYStreck, LLC20260—
+3K231221MDx-Chex for BC-GPStreck20231—
+3K231223MDx-Chex for BC-GNStreck20231—
+4K260041MDx-Chex for BCPStreck, LLC20260—
+4K254166MDx-Chex for BCNStreck20260—