510(k) Report

Devices descending from K221253

3 later devices reach SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230868SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative…Maine Molecular Quality Controls, Inc.20232—
+2K233611SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE…Maine Molecular Quality Controls, Inc.20241—
+3K241289SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc.20240—