Advandx, Inc. - FDA 510(k) Cleared Devices

Cleared Oct 10, 2014

MECA XPRESSFISH

K140619 · MYI

Microbiology · 213d

Cleared Jul 21, 2013

GRAM-NEGATIVE QUICKFISH BC

K123418 · JSS

Microbiology · 257d

Cleared Jan 07, 2013

ENTEROCOCCUS QUICKFISH BC

K121991 · OAH

Microbiology · 185d

Cleared Apr 03, 2012

STAPHYLOCOCCUS QUICKFISH BC

K113371 · NXX

Microbiology · 139d

Cleared Dec 16, 2010

GNR TRAFFIC LIGHT PNA FISH

K101558 · JSS

Microbiology · 195d

Cleared Jul 15, 2010

YEAST TRAFFIC LIGHT PNA FISH

K093024 · NZS

Microbiology · 289d

Cleared Mar 12, 2010

C. ALBICANS/C. GLABRATA PNA FISH

K092784 · NZS

Microbiology · 183d

Cleared Jan 19, 2010

C. ALBICANS PNA FISH

K092655 · NZS

Microbiology · 144d

Cleared Dec 16, 2009

E.COLI/P. AERUGINOSA PNA FISH

K092236 · JSS

Microbiology · 146d

Cleared Nov 23, 2009

S. AUREUS/CNS PNA FISH, MODEL KT005

K092166 · NXX

Microbiology · 125d

Cleared Sep 01, 2009

EK/P. AERUGINOSA PNA FISH

K092393 · JSS

Microbiology · 27d

Cleared Aug 18, 2009

S. AUREUS PNA FISH

K091827 · NXX

Microbiology · 60d