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

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K103798	BECTON DICKINSON & CO.	BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS	03/18/2011
K111951	BIOHELIX CORPORATION	ISOAMP HSV ASSAY	09/27/2011
K100336	ERAGEN BIOSCIENCES	MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711	05/12/2010
K111527	ERAGEN BIOSCIENCES, INC.	MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT	08/03/2011
K150962	FOCUS DIAGNOSTICS	Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack	08/28/2015
K162673	HOLOGIC, INC.	Aptima Herpes Simplex Viruses 1 & 2 Assay	06/15/2017
K140198	Intelligent Medical Devices, Inc.	IMDX HSV-1/2 FOR ABBOTT M2000	05/13/2014
K142738	QIAGEN	artus HSV-1/2 QS-RGQ MDx Kit	12/19/2014
K140029	QUIDEL CORPORATION	AMIPLIVUE HSV 1&2 ASSAY	03/26/2014
K150617	ROCHE MOLECULAR SYSTEMS, INC.	cobas HSV 1 and 2 Test	06/01/2015
K142156	SEEGENE	SEEGENE ANYPLEX II HSV-1/2 ASSAY	02/13/2015
K172509	Vela Diagnostics USA Inc.	Sentosa SA201 HSV 1/2 Qualitative PCR Test	02/01/2018