First To Know Syphilis Test
FDA 510(k) clearance DEN230090 · decided 2024-08-16
Clearance details
- K-number
- DEN230090
- Device name
- First To Know Syphilis Test
- Applicant
- Nowdiagnostics
- Decision
- Unknown
- Date received
- 2023-12-27
- Decision date
- 2024-08-16
- Days to decision
- 233 days
- Clearance type
- Direct
- Product code
- SBZ
- Device class
- 2
- Regulation number
- 866.3986
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Springdale, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.