510(k) Report

Devices descending from K153219

1 later device reach ProFlu+ Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171963Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion…Hologic, Inc.201701