K232643
- 510(k) number
- K232643
- Device name
- Cue COVID-19 Molecular Test
- Applicant
- Cue Health, Inc. CA · US
- Product code
- QWB — Over-The-Counter Molecular Test To Detect Sars-Cov-2
- Decision date
- 2023-11-28
- Date received
- 2023-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K232643.pdf
Official FDA record: K232643
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.