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.

Advandx, Inc. — FDA 510(k) Products and Clearance History

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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