Medical Device Manufacturer · US , Canton , MA

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

21 submissions · 21 cleared · Since 2006
21
Total
21
Cleared
0
Denied

Advandx, Inc. has 21 FDA 510(k) cleared microbiology devices. Based in Canton, US.

Historical record: 21 cleared submissions from 2006 to 2014.

Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

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

21 devices
1-21 of 21
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
Cleared Jul 24, 2009
AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
K083074 · OAH
Microbiology · 282d
Cleared Jun 25, 2009
E. COLI PNA FISH
K082068 · JSS
Microbiology · 338d
Cleared May 05, 2009
GBS PNA FISH
K082612 · OAH
Microbiology · 238d
Cleared Mar 26, 2009
EK/P. AERUGINOSA PNA FISH
K081433 · JSS
Microbiology · 309d
Cleared Dec 19, 2008
E.COLI/P. AERUGINOSA PNA FISH
K081309 · JSS
Microbiology · 224d
Cleared Sep 12, 2008
YEAST TRAFFIC LIGHT PNA FISH
K080719 · JXB
Microbiology · 183d
Cleared Dec 22, 2006
ENTEROCOCCUS FAECALIS PNA FISH
K063127 · OAH
Microbiology · 70d
Cleared Oct 25, 2006
C. ALBICANS PNA FISH
K062461 · JXB
Microbiology · 63d
Cleared May 08, 2006
S. AUREUS PNA FISH
K060099 · NXX
Microbiology · 115d
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