First To Know Syphilis Test— 510(k) DEN230090

Unknown

Nowdiagnostics

FDA 510(k) clearance DEN230090 for First To Know Syphilis Test, Unknown on 2024-08-16. Applicant: Nowdiagnostics. Device class: 2.

Clearance details

Applicant
Nowdiagnostics
Product code
Code SBZ
Device class
Class 2
Regulation
21 CFR 866.3986
Advisory panel
Microbiology
Date received
Decision date
Decision
Unknown
Clearance type
Direct
Location
Springdale, AZ, US
View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.