WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest (K243256)
Description
WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest by Wondfo USA Co., Ltd., an FDA 510(k) cleared microbiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243256
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest (K243256) cites 0 predicate devices and is itself cited by 2 later devices.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251604 | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | Access Bio, Inc. | 2025 |
| K251563 | WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test | Wondfo USA Co, Ltd. | 2025 |
Trace the full predicate network for K243256
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.