FDA 510(k) Applications for Medical Device Product Code: OOI (Real Time Nucleic Acid Amplification System)

FDA 510(k) Applications for Medical Device Product Code "OOI"
(Real Time Nucleic Acid Amplification System)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K092705	ABBOTT MOLECULAR, INC.	ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501	05/28/2010
K151690	ALERE SCARBOROUGH, INC.	Alere i Instrument, Alere i Influenza A & B, Alere i Strep A	07/16/2015
K140447	Becton, Dickinson and Company	BD VIPER LT SYSTEM	05/20/2014
K093383	BIOMERIEUX, INC.	NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG	07/06/2010
K102314	FOCUS DIAGNOSTICS, INC.	3M INTEGRATED CYCLER (110V) & (220V)	10/29/2010
K170558	GenePOC Inc.	revogene	05/25/2017
K123955	LIFE TECHNOLOGIES CORPORATION	QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT	03/08/2013
K161495	LUMINEX CORPORATION	ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)	06/30/2016
K151917	LUMINEX CORPORATION	ARIES System	10/06/2015
K160517	LUMINEX CORPORATION	ARIES System	04/12/2016
K220480	Meridian Bioscience, Inc	Revogene	07/11/2022
K222779	Meridian Bioscience, Inc	Revogene	01/26/2023
K113319	QIAGEN, GMBH	ROTOR-GENE Q MDX	02/06/2012