510(k) Report

Devices descending from K060652

14 later devices reach Tigris DTS Gen-Probe Aptima Combo 2 Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200436Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test…Hologic, Inc.20202—
+1K110923Cobas 4800 CT / NG TestRoche Molecular Systems, Inc.2012102
+2K200866Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)Hologic, Inc.20201—
+2K163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc.20177—
+2K140887Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc.20140—
+2K132270Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc.20139—
+3K220321Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris…Hologic, Inc.20220—
+3K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.20186—
+4K240217cobas® liat CT/NG nucleic acid testRoche Molecular Systems, Inc.20250—
+4K240197cobas® liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.20250—
+4K202408cobas CTNG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.20213—
+5K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…Roche Molecular Systems, Inc.20260—
+5K253759cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.20260—
+5K253756cobas liat CT/NG nucleic acid testRoche Molecular Systems, Inc.20260—