510(k) Report

Devices descending from K233611

1 later device reach SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241289SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc.20240—