510(k) Report

Devices descending from K231306

1 later device reach cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240867cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 SystemsRoche Molecular Systems, Inc.20250—