Medical Device Manufacturer · US , Canton , MA

Advandx, Inc.

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

Advandx, Inc. — FDA 510(k) Submissions

Advandx, Inc. has submitted 21 FDA 510(k) premarket notifications since 2006, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Kit, Identification, Enterobacteriaceae, Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus, Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis, Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast, Kit, Identification, Yeast . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
MECA XPRESSFISH
K140619 · MYI System, Test, Genotypic... · Microbiology
Oct 2014 213d
GRAM-NEGATIVE QUICKFISH BC
K123418 · JSS Kit, Identification,... · Microbiology
Jul 2013 257d
ENTEROCOCCUS QUICKFISH BC
K121991 · OAH Fish (fluorescent In Situ... · Microbiology
Jan 2013 185d
STAPHYLOCOCCUS QUICKFISH BC
K113371 · NXX Fish (fluorescent In Situ... · Microbiology
Apr 2012 139d
GNR TRAFFIC LIGHT PNA FISH
K101558 · JSS Kit, Identification,... · Microbiology
Dec 2010 195d
YEAST TRAFFIC LIGHT PNA FISH
K093024 · NZS Fish (fluorescent In Situ... · Microbiology
Jul 2010 289d
C. ALBICANS/C. GLABRATA PNA FISH
K092784 · NZS Fish (fluorescent In Situ... · Microbiology
Mar 2010 183d
C. ALBICANS PNA FISH
K092655 · NZS Fish (fluorescent In Situ... · Microbiology
Jan 2010 144d
E.COLI/P. AERUGINOSA PNA FISH
K092236 · JSS Kit, Identification,... · Microbiology
Dec 2009 146d
S. AUREUS/CNS PNA FISH, MODEL KT005
K092166 · NXX Fish (fluorescent In Situ... · Microbiology
Nov 2009 125d
EK/P. AERUGINOSA PNA FISH
K092393 · JSS Kit, Identification,... · Microbiology
Sep 2009 27d
S. AUREUS PNA FISH
K091827 · NXX Fish (fluorescent In Situ... · Microbiology
Aug 2009 60d
AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
K083074 · OAH Fish (fluorescent In Situ... · Microbiology
Jul 2009 282d
E. COLI PNA FISH
K082068 · JSS Kit, Identification,... · Microbiology
Jun 2009 338d
GBS PNA FISH
K082612 · OAH Fish (fluorescent In Situ... · Microbiology
May 2009 238d
EK/P. AERUGINOSA PNA FISH
K081433 · JSS Kit, Identification,... · Microbiology
Mar 2009 309d
E.COLI/P. AERUGINOSA PNA FISH
K081309 · JSS Kit, Identification,... · Microbiology
Dec 2008 224d
YEAST TRAFFIC LIGHT PNA FISH
K080719 · JXB Kit, Identification, Yeast · Microbiology
Sep 2008 183d
ENTEROCOCCUS FAECALIS PNA FISH
K063127 · OAH Fish (fluorescent In Situ... · Microbiology
Dec 2006 70d
C. ALBICANS PNA FISH
K062461 · JXB Kit, Identification, Yeast · Microbiology
Oct 2006 63d
S. AUREUS PNA FISH
K060099 · NXX Fish (fluorescent In Situ... · Microbiology
May 2006 115d
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