FDA 510(k)

iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro

K-Nummer: K251085 · 2025-12-12

Entscheidungsdatum2025-12-12

ProduktcodeSCA

BeratungsausschussMI

EntscheidungSubstantially Equivalent

Produktübersicht

iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro is the device name listed in this FDA 510(k) record. The listed applicant is Ihealth Labs, Inc.. It received FDA 510(k) clearance on 2025-12-12 under 510(k) number K251085. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro?

iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Ihealth Labs, Inc.. The 510(k) number is K251085.

When did iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro receive FDA 510(k) clearance?

iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro received FDA 510(k) clearance on 2025-12-12, under 510(k) number K251085.

Who is the listed applicant for iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro?

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

What is the FDA product code for iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro?

The FDA product code for iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro is SCA.

Zugehörige klinische Studien

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Weitere Einträge mit Ihealth Labs, Inc. als Antragsteller

K251092iHealth Grippe A&B/COVID-19 Schnelltest; iHealth Grippe A&B/COVID-19 Schnelltest Pro K243146iCare APP K233842iHealth COVID-19 Antigen Rapid Test

Verwandte Geräte (Code: SCA)

K261212Flowflex Plus RSV + Flu A/B + COVID Rapid TestACON Laboratories, Inc.K251092iHealth Grippe A&B/COVID-19 Schnelltest; iHealth Grippe A&B/COVID-19 Schnelltest 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.K251563WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestWondfo USA Co, Ltd.

Offizielle Quelle

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