FDA 510(k)

Flowflex Plus COVID-19 + Flu A/B Home Test

N.º K: K250377 · 2025-05-10

Fecha de decisión2025-05-10

Código de productoSCA

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

Flowflex Plus COVID-19 + Flu A/B Home Test is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2025-05-10 under 510(k) number K250377. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Flowflex Plus COVID-19 + Flu A/B Home Test?

Flowflex Plus COVID-19 + Flu A/B Home Test is a medical device that received FDA 510(k) clearance on 2025-05-10. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K250377.

When did Flowflex Plus COVID-19 + Flu A/B Home Test receive FDA 510(k) clearance?

Flowflex Plus COVID-19 + Flu A/B Home Test received FDA 510(k) clearance on 2025-05-10, under 510(k) number K250377.

Who is the listed applicant for Flowflex Plus COVID-19 + Flu A/B Home Test?

The FDA 510(k) record lists ACON Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flowflex Plus COVID-19 + Flu A/B Home Test?

The FDA product code for Flowflex Plus COVID-19 + Flu A/B Home Test is SCA.

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Otros registros que enlistan a ACON Laboratories, Inc. como solicitante

K261212Flowflex Plus RSV + Flu A/B + COVID Rapid Test K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip K251749Flowflex Plus RSV + Flu A/B + COVID Home Test K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System K232715Distinct® Digital Pregnancy Test K233373Flowflex® Plus COVID-19 Home Test

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Dispositivos relacionados (Código: SCA)

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.

Fuente oficial

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