K233373
- 510(k) number
- K233373
- Device name
- Flowflex® Plus COVID-19 Home Test
- Applicant
- ACON Laboratories, Inc. CA · US
- Product code
- QYT — Over-The-Counter Covid-19 Antigen Test
- Decision date
- 2024-04-19
- Date received
- 2023-10-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K233373
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.