510(k) Report

Devices descending from K141338

8 later devices reach Liat Strep a Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201269Accula Strep A TestMesa Biotech, Inc.20200—
+1K200065cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza…Roche Molecular Systems, Inc.20203—
+1K173398Xpert Xpress Strep ACepheid20180—
+1K172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitLuminex Corporation201701
+1K172126Xpert Xpress Strep ACepheid201702
+2K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…Roche Molecular Systems, Inc.20260—
+2K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20211—
+3K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20220—