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FDA 510(k)

WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest

K-Number: K243256 · 2025-01-16

ApplicantWondfo USA Co, Ltd.
Decision Date2025-01-16
Product CodeSCA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest is a medical device manufactured by Wondfo USA Co, Ltd.. It received FDA 510(k) clearance on 2025-01-16 under approval number K243256. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest?

WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest is a medical device that received FDA 510(k) clearance on 2025-01-16. It is manufactured by Wondfo USA Co, Ltd.. The 510(k) number is K243256.

When was WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest approved by the FDA?

WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest received FDA 510(k) clearance on 2025-01-16, under approval number K243256.

What company makes WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest?

WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest is manufactured by Wondfo USA Co, Ltd..

What is the FDA product code for WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest?

The FDA product code for WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest is SCA.

Related Clinical Trials

NCT07610967 Light-based Immunomodulation for Guarding Against Human Respiratory Tract Infections NOT_YET_RECRUITING NCT07516977 Noseguard for Prevention of Respiratory Infections in Real-World Use NOT_YET_RECRUITING

Other Devices by Wondfo USA Co, Ltd.

K251563WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test

Related Devices (Code: SCA)

DEN240029Healgen Rapid Check COVID-19/Flu A&B Antigen TestHealgen K251092iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProIhealth Labs, Inc. K251085iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProIhealth Labs, Inc. K251538Status™ COVID-19/Flu A&BPrinceton BioMeditech Corp. K251749Flowflex Plus RSV + Flu A/B + COVID Home TestACON Laboratories, Inc. K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestAccess Bio, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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