K233842
- 510(k) number
- K233842
- Device name
- iHealth COVID-19 Antigen Rapid Test
- Applicant
- Ihealth Labs, Inc. CA · US
- Product code
- QYT — Over-The-Counter Covid-19 Antigen Test
- Decision date
- 2024-05-31
- Date received
- 2023-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233842.pdf
Official FDA record: K233842
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.