510(k) Report

Devices descending from K955562

4 later devices reach Innofluor Phenytoin Assay System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051211QMS Zonisamide Reagents, Calibrators and ControlsSeradyn, Inc.20053—
+2K091884Ark Zonisamide Assay, Ark Zonisamide Calibrator, and Ark Zonisamide Contro, Models…Ark Diagnostics, Inc.20090—
+2K062966QMS Lamotrigine Assay (Reagents), Calibrators & ControlsSeradyn, Inc.20071—
+3K101305Ark Lamotrigine Assay, Calibrator & ControlArk Diagnostics, Inc.20100—