iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro— 510(k) K251085

Name: FDA 510(k) clearance K251085
Creator: U.S. Food and Drug Administration
Published: 2025-12-12

Substantially Equivalent

Ihealth Labs, Inc.

FDA 510(k) clearance K251085 for iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro, Substantially Equivalent on 2025-12-12. Applicant: Ihealth Labs, Inc.. Device class: 2.

Clearance details

Applicant: Ihealth Labs, Inc.
Product code: Code SCA
Device class: Class 2
Regulation: 21 CFR 866.3987
Advisory panel: Microbiology
Date received: 2025-04-09
Decision date: 2025-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code SCA

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K261212 — Flowflex Plus RSV + Flu A/B + COVID Rapid Test2026-07-10
K251092 — iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro2025-12-12
K251538 — Status COVID-19/Flu A&B2025-11-14
K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test2025-10-22
K251604 — CareSuperb COVID-19/Flu A&B Antigen Combo Home Test2025-08-22

More clearances from Ihealth Labs, Inc.

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K243146 — iCare APP2025-02-03
K233842 — iHealth COVID-19 Antigen Rapid Test2024-05-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.