FDA 510(k)

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

Número K: K251563 · 2025-08-20

Data da decisão2025-08-20

Código do produtoSCA

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Wondfo USA Co, Ltd. como candidato(a)

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

Dispositivos Relacionados (Código: SCA)

K261212Flowflex Plus RSV + Flu A/B + COVID Rapid TestACON Laboratories, Inc.K251092iHealth Flu A&B/COVID-19 Rápido Test; iHealth Flu A&B/COVID-19 Rápido 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.

Fonte oficial

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