K232377
- 510(k) number
- K232377
- Device name
- Healgen Rapid COVID-19 Antigen Test
- Applicant
- Healgen Scientific,, LLC TX · US
- Product code
- QVF — Simple Point-Of-Care Device To Directly Detect Sars-
- Decision date
- 2024-04-19
- Date received
- 2023-08-08
- 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: K232377.pdf
Official FDA record: K232377
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.