510(k) Report

Devices descending from K221925

3 later devices reach ID Now Covid-19 2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.20260—
+1K223783cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20231—
+2K243346cobas liat SARS-CoV-2 v2 nucleic acid testRoche Molecular Systems, Inc.20250—