Medical Device Manufacturer · US , Canton , MA

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

21 submissions · 21 cleared · Since 2006

Recent clearances: MECA XPRESSFISH, GRAM-NEGATIVE QUICKFISH BC, ENTEROCOCCUS QUICKFISH BC

21

Total

21

Cleared

0

Denied

FDA 510(k) Regulatory Record - Advandx, Inc. Microbiology ✕

21 devices

1-12 of 21

Cleared Oct 10, 2014

MECA XPRESSFISH

Microbiology · 213d

Cleared Jul 21, 2013

GRAM-NEGATIVE QUICKFISH BC

Microbiology · 257d

Cleared Jan 07, 2013

ENTEROCOCCUS QUICKFISH BC

Microbiology · 185d

Cleared Apr 03, 2012

STAPHYLOCOCCUS QUICKFISH BC

Microbiology · 139d

Cleared Dec 16, 2010

GNR TRAFFIC LIGHT PNA FISH

Microbiology · 195d

Cleared Jul 15, 2010

YEAST TRAFFIC LIGHT PNA FISH

Microbiology · 289d

Cleared Mar 12, 2010

C. ALBICANS/C. GLABRATA PNA FISH

Microbiology · 183d

Cleared Jan 19, 2010

C. ALBICANS PNA FISH

Microbiology · 144d

Cleared Dec 16, 2009

E.COLI/P. AERUGINOSA PNA FISH

Microbiology · 146d

Cleared Nov 23, 2009

S. AUREUS/CNS PNA FISH, MODEL KT005

Microbiology · 125d

Cleared Sep 01, 2009

EK/P. AERUGINOSA PNA FISH

Microbiology · 27d

Cleared Aug 18, 2009

S. AUREUS PNA FISH

Microbiology · 60d