iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro— 510(k) K251092
Substantially EquivalentIhealth Labs, Inc.
FDA 510(k) clearance K251092 for iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro, Substantially Equivalent on 2025-12-12. Applicant: Ihealth Labs, Inc.. Device class: 2.
Clearance details
- Applicant
- Ihealth Labs, Inc.
- Product code
- Product code SCA
- Device class
- Class 2
- Regulation
- 21 CFR 866.3987
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code SCA
view all- K262432 — CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test
- K261212 — Flowflex Plus RSV + Flu A/B + COVID Rapid Test
- K251085 — iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro
- K251538 — Status COVID-19/Flu A&B
- K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test
More clearances from Ihealth Labs, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.