K251092
- 510(k) number
- K251092
- Device name
- iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
- Applicant
- Ihealth Labs, Inc. CA · US
- Product code
- SCA — Multi-Analyte Respiratory Virus Antigen Detection Te
- Decision date
- 2025-12-12
- Date received
- 2025-04-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K251092.pdf
Official FDA record: K251092
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.