510(k) Report

Devices descending from K935375

1 later device reach Axsym Phenytoin Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080696Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and…Abbott Laboratories20080—