FDA 510(k) Applications for Medical Device Product Code: OOU (Parainfluenza Multiplex Nucleic Acid Assay)

FDA 510(k) Applications for Medical Device Product Code "OOU"
(Parainfluenza Multiplex Nucleic Acid Assay)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K132238	GEN-PROBE PRODESSE, INC.	PROPARAFLU+ ASSAY	08/26/2013
K172282	Hologic, Inc.	Panther Fusion Paraflu Assay	10/23/2017
K153223	HOLOGIC, INC.	ProParaFlu+ Assay	12/09/2015
K091053	PRODESSE, INC.	PROPARAFLU+ASSAY	11/20/2009
K141927	QUIDEL CORPORATION	LYRA PARAINFLUENZA VIRUS ASSAY	10/09/2014