510(k) Report

Devices descending from K243256

4 later devices reach WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251085iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProIhealth Labs, Inc.20250—
+1K251092iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProIhealth Labs, Inc.20250—
+1K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestAccess Bio, Inc.20250—
+1K251563WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestWondfo USA Co, Ltd.20250—