510(k) Report

Devices descending from K200010

7 later devices reach FilmArray BCID2 Control Panel M416 through their predicates, nearest generation first.

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