510(k) Report

Devices descending from DEN240029

8 later devices reach Healgen Rapid Check COVID-19/Flu A&B Antigen Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251538Status™ COVID-19/Flu A&BPrinceton BioMeditech Corp.20250—
+1K243561Nano-Check Influenza+COVID-19 Dual TestNano-Ditech Corporation20250—
+1K243256WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B…Wondfo USA Co, Ltd.20254—
+1K243262QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro TestOsang, LLC20250—
+2K251085iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProIhealth Labs, Inc.20250—
+2K251092iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProIhealth Labs, Inc.20250—
+2K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestAccess Bio, Inc.20250—
+2K251563WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestWondfo USA Co, Ltd.20250—