FDAnews
www.fdanews.com/articles/114204-advandx-receives-fda-510-k-clearance

AdvanDx Receives FDA 510(k) Clearance

January 30, 2009
AdvanDx announced it received FDA 510(k) clearance for E. coli/P. aeruginosa PNA FISH to identify Escherichia coli and/or Pseudomonas aeruginosa directly from positive blood cultures.
Yahoo! Finance