Healgen Rapid Check COVID-19/Flu A&B Antigen Test
FDA 510(k) clearance DEN240029 · decided 2024-10-07
Clearance details
- K-number
- DEN240029
- Device name
- Healgen Rapid Check COVID-19/Flu A&B Antigen Test
- Applicant
- Healgen
- Decision
- Unknown
- Date received
- 2024-06-07
- Decision date
- 2024-10-07
- Days to decision
- 122 days
- Clearance type
- Direct
- Product code
- SCA
- Device class
- 2
- Regulation number
- 866.3987
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.