510(k) Report

Devices descending from K200866

1 later device reach Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220321Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris…Hologic, Inc.20220—