510(k) Report

Devices descending from K213804

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)Abbott Molecular20240—
+1K231306cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsRoche Molecular Systems, Inc.20231—
+2K240867cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 SystemsRoche Molecular Systems, Inc.20250—