510(k) Report

Devices descending from K202196

6 later devices reach BioFire RP2.1/RP2.1plus Control Panel M441 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc.20251—
+1K221253SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc.20233—
+2K260577FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc.20260—
+2K230868SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative…Maine Molecular Quality Controls, Inc.20232—
+3K233611SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE…Maine Molecular Quality Controls, Inc.20241—
+4K241289SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc.20240—