510(k) Report

Devices descending from K163260

2 later devices reach SeptiCyte LAB through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203748SeptiCyte RAPIDImmunexpress, Inc.20211—
+2K241676TriVerityInflammatix, Inc.20250—