K250377
- 510(k) number
- K250377
- Device name
- Flowflex Plus COVID-19 + Flu A/B Home Test
- Applicant
- ACON Laboratories, Inc. CA · US
- Product code
- SCA — Multi-Analyte Respiratory Virus Antigen Detection Te
- Decision date
- 2025-05-10
- Date received
- 2025-02-10
- 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: K250377
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.