510(k) DEN230090
- Device
- First To Know Syphilis Test
- Applicant
- Nowdiagnostics
- 510(k) number
- DEN230090
- Product code
- SBZ
- Decision
- Unknown (DENG)
- Decision date
- 2024-08-16
- Date received
- 2023-12-27
- Regulation
- 866.3986
- Classification name
- Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kevin Clark
- Address
- 1200 Stewart Pl. Springdale AZ US 72764 72764
FDA Registration Numbers#
- 3010864358
Source Documents#
510(k) summary PDF not indicated by FDA