510(k) Report

Devices descending from K940596

2 later devices reach Axsym Phenobarbital through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081231Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33…Abbott Laboratories20081—
+2K210858VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc.20210—