K-number	DEN230090
Device name	First To Know Syphilis Test
Applicant	Nowdiagnostics
Product code	SBZ
Device class	Class II
Decision date	Aug 16, 2024
Decision	Not Substantially Equivalent
Regulation	866.3986

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Source

View the full FDA submission: accessdata.fda.gov

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First To Know Syphilis Test

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