510(k) Report

Devices descending from K051211

3 later devices reach QMS Zonisamide Reagents, Calibrators and Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091884Ark Zonisamide Assay, Ark Zonisamide Calibrator, and Ark Zonisamide Contro, Models…Ark Diagnostics, Inc.20090—
+1K062966QMS Lamotrigine Assay (Reagents), Calibrators & ControlsSeradyn, Inc.20071—
+2K101305Ark Lamotrigine Assay, Calibrator & ControlArk Diagnostics, Inc.20100—