FDA 510(k) Applications for Medical Device Product Code: JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar)

FDA 510(k) Applications for Medical Device Product Code "JSO"
(Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K092767	BECTON DICKINSON & CO.	BBL CHROMAGAR MRSA II	08/20/2010
K042812	BECTON DICKINSON & CO.	BBLCHROMAGAR MRSA	11/22/2004
K100589	BIO-RAD	MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS	10/29/2010
K070361	BIO-RAD	MRSASELECT	09/13/2007
K081212	BIO-RAD	MRSASELECT - EXTENDED INCUBATION	06/13/2008
K171061	Bio-Rad	MRSASelect II	12/28/2017
K103684	BIO-RAD	VRESELECT CULTURE MEDIUM	10/21/2011
K122187	BIO-RAD	VRESELECT CULTURE MEDIUM	11/06/2012
K181092	bioMerieux SA	CHROMID CARBA agar (CARB)	07/06/2018
K151688	bioMerieux, Inc.	chromID MRSA	03/11/2016
K162076	bioMerieux, Inc.	chromID MRSA	10/25/2016
K091024	BIOMERIEUX, INC.	CHROMID MRSA AGAR, MODEL: REF 43 841	07/17/2009
K091025	BIOMERIEUX, INC.	CHROMID VRE AGAR, MODEL: REF 43 851	03/02/2010
K952595	CLINICAL STANDARDS LABORATORIES, INC.	HAEMOPHILUS TEST MEDIUM (HTM)	04/10/1996
K964560	HARDY DIAGNOSTICS	BHI W/VANCOMYCIN AGAR	01/15/1997
K190553	Hardy Diagnostics	HardyCHROM CRE	04/29/2019
K160512	HARDY DIAGNOSTICS	HardyCHROM ESBL	11/15/2016
K102922	HARDY DIAGNOSTICS	HARDYCHROM MRSA	05/04/2011
K962744	PREPARED MEDIA LABORATORY, INC.	HAEMOPHILUS TEST MEDIUM AGAR (HTM)	10/15/1996
K162620	REMEL, INC.	Remel Spectra ESBL	05/01/2017
K092407	REMEL, INC.	REMEL SPECTRA MRSA	10/08/2010
K972359	REMEL, L.P.	REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN	08/28/1997
K092819	Thermo Fisher Scientific	REMEL SPECTRA VRE	07/15/2010
K073027	Thermo Fisher Scientific	SPECTRA MRSA	02/28/2008