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FDA 510(k)

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

K-Number: K251563 · 2025-08-20

ApplicantWondfo USA Co, Ltd.
Decision Date2025-08-20
Product CodeSCA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test is a medical device manufactured by Wondfo USA Co, Ltd.. It received FDA 510(k) clearance on 2025-08-20 under approval number K251563. 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 Flu A&B Home Test; WELLlife Influenza A&B Test?

WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test is a medical device that received FDA 510(k) clearance on 2025-08-20. It is manufactured by Wondfo USA Co, Ltd.. The 510(k) number is K251563.

When was WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test approved by the FDA?

WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test received FDA 510(k) clearance on 2025-08-20, under approval number K251563.

What company makes WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test?

WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test is manufactured by Wondfo USA Co, Ltd..

What is the FDA product code for WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test?

The FDA product code for WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test is SCA.

Other Devices by Wondfo USA Co, Ltd.

K243256WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest

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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