FDA 510(k) Applications for Medical Device Product Code: SAN ()

FDA 510(k) Applications for Medical Device Product Code "SAN"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K211815	Affinity Biosensors	LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System	04/02/2024
K241324	Affinity Biosensors, LLC	LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system	10/23/2024
K221688	Q-linea AB	ASTar BC G- Kit and ASTar Instrument	04/26/2024
K230675	Specific Diagnostics, LLC	VITEK REVEAL GN AST Assay and VITEK REVEAL AST System	06/20/2024