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..
Clearance details
- Applicant
- Ihealth Labs, Inc.
- Product code
- Code SCA
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.