K-number	K241534
Device name	VITROS Immunodiagnostic Products Syphilis Reagent Pack
Applicant	Ortho Clinical Diagnostics
Product code	LIP
Device class	Class II
Decision date	Aug 28, 2024
Decision	Substantially Equivalent
Regulation	866.3830

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS Immunodiagnostic Products Syphilis Reagent Pack

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