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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 the device name listed in this FDA 510(k) record. The listed applicant is Wondfo USA Co, Ltd.. It received FDA 510(k) clearance on 2025-08-20 under 510(k) 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. The listed applicant is Wondfo USA Co, Ltd.. The 510(k) number is K251563.

When did WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test receive FDA 510(k) clearance?

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

Who is the listed applicant for WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test?

The FDA 510(k) record lists Wondfo USA Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Wondfo USA Co, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: SCA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261212Flowflex Plus RSV + Flu A/B + COVID Rapid TestACON Laboratories, Inc.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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