DEN240029
- 510(k) number
- DEN240029
- Device name
- Healgen Rapid Check COVID-19/Flu A&B Antigen Test
- Applicant
- Healgen TX · US
- Product code
- SCA — Multi-Analyte Respiratory Virus Antigen Detection Te
- Decision date
- 2024-10-07
- Date received
- 2024-06-07
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Microbiology
Official FDA record: DEN240029
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.