FDA 510(k) Applications for Medical Device Product Code "JSS"
(Kit, Identification, Enterobacteriaceae)

FDA 510(k) Number Applicant Device Name Decision Date
K082068 ADVANDX, INC. E. COLI PNA FISH 06/25/2009
K081309 ADVANDX, INC. E.COLI/P. AERUGINOSA PNA FISH 12/19/2008
K092236 ADVANDX, INC. E.COLI/P. AERUGINOSA PNA FISH 12/16/2009
K081433 ADVANDX, INC. EK/P. AERUGINOSA PNA FISH 03/26/2009
K092393 ADVANDX, INC. EK/P. AERUGINOSA PNA FISH 09/01/2009
K101558 ADVANDX, INC. GNR TRAFFIC LIGHT PNA FISH 12/16/2010
K123418 ADVANDX, INC. GRAM-NEGATIVE QUICKFISH BC 07/21/2013
K150031 MIACOM DIAGNOSTICS GMBH hemoFISH Masterpanel 10/01/2015


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