510(k) Report

Devices descending from DEN210040

3 later devices reach VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252280Elecsys Anti-SARS-CoV-2 SRoche Diagnostics20260—
+1K250768Elecsys Anti-SARS-CoV-2Roche Diagnostics20251—
+2K253839Elecsys Anti-SARS-CoV-2Roche Diagnostics20250—