510(k) Report

Devices descending from K220963

3 later devices reach Simplexa COVID-19 & Flu A/B Direct through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.20261—
+1K242526Visby Medical Respiratory Health TestVisby Medical, Inc.20250—
+2K261837FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.20260—