510(k) Report

Devices descending from K082118

2 later devices reach Xpert Hemosil Factor II & Factor V Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223046Xpert® FII & FVCepheid®20231—
+2K250218Xpert® FII & FVCepheid20250—