DEN230090
- 510(k) number
- DEN230090
- Device name
- First To Know Syphilis Test
- Applicant
- Nowdiagnostics AZ · US
- Product code
- SBZ — Test For Detection Of Antibodies Associated With Syp
- Decision date
- 2024-08-16
- Date received
- 2023-12-27
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Microbiology
Official FDA record: DEN230090
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.