FDA 510(k) Applications for Medical Device Product Code: NPR (Test, Factor Ii G20210a Mutations, Genomic Dna Pcr)

FDA 510(k) Applications for Medical Device Product Code "NPR"
(Test, Factor Ii G20210a Mutations, Genomic Dna Pcr)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K250218	Cepheid	Xpert« FII & FV	02/21/2025
K223046	Cepheid«	Xpert« FII & FV	02/15/2023
K100943	HOLOGIC, INC.	INVADER FACTOR II	06/02/2011
K033612	ROCHE DIAGNOSTICS CORP.	FACTOR II (PROTHROMBIN) G20210A KIT	12/18/2003
K172913	Roche Molecular Systems, Inc.	cobas Factor II and Factor V Test	01/12/2018