FDA 510(k) Applications for Medical Device Product Code "NIJ"
(System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species)

FDA 510(k) Number Applicant Device Name Decision Date
K102416 BD DIAGNOSTICS SCIENCE BD GENEOHM VANR ASSAY 10/20/2011
K092953 CEPHEID XPERT VANA ASSAY 12/17/2009
K061686 GENEOHM SCIENCES CANADA, INC. IDI-VANR ASSAY 08/30/2006
K020576 ID BIOMEDICAL CORP. VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE 05/01/2002
K123753 INTELLIGENT MEDICAL DEVICES, INC IMDX VANR FOR ABBOTT M2000 07/17/2013


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