510(k) Report

Devices descending from K951550

2 later devices reach CMV Brite Antigenemia Test Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991650CMV Brite Turbo KitBiotest Diagnostics Corp.19990—
+1K982311Bartels Cinakit CMV AntigenemiaIntracel Corp.19980—