Medical Device Manufacturer · US , San Diego , CA

Inova Diagnostics, Inc. - FDA 510(k) Cleared Devices

138 submissions · 136 cleared · Since 1988
138
Total
136
Cleared
2
Denied
129 devices
26-50 of 129
Cleared Feb 07, 2014
QUANTA FLASH CENTROMERE
K123880 · LJM
Immunology · 417d
Cleared May 07, 2013
QUANTA FLASH ENA7
K122923 · LLL
Immunology · 225d
Cleared Apr 17, 2013
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH...
K123593 · LKP
Immunology · 147d
Cleared Feb 26, 2013
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
K120817 · MID
Immunology · 344d
Cleared Sep 20, 2012
QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS,...
K113863 · MST
Immunology · 265d
Cleared Jul 31, 2012
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
K112545 · MOB
Immunology · 334d
Cleared Oct 20, 2011
QUANTA FLASH (TM) DGP SCREEN
K111414 · MST
Immunology · 153d
Cleared Mar 23, 2011
QUANTA FLASH H-TTG IGG
K101644 · MVM
Immunology · 286d
Cleared Oct 13, 2010
QUANTA FLASH H-TTG IGA
K094060 · MVM
Immunology · 286d
Cleared Feb 01, 2010
QUANTA LITE APS/PT IGG AND IGM ELISA
K090755 · OPN
Immunology · 318d
Cleared Oct 27, 2008
QUANTA LITE OMP PLUS ELISA
K081248 · OKM
Immunology · 178d
Cleared Mar 05, 2008
QUANTA LITE CCP3.1 IGG/IGA ELISA
K072944 · NHX
Immunology · 140d
Cleared Feb 12, 2008
QUANTA LITE H-TTG SCREEN
K073145 · MVM
Immunology · 96d
Cleared Feb 11, 2008
QUANTA PLEX CELIAC IGG PROFILE
K072632 · MVM
Immunology · 146d
Cleared Jan 28, 2008
QUANTA LITE F-ACTIN IGA ELISA
K072967 · MVM
Immunology · 98d
Cleared Jun 20, 2007
QUANTA PLEX CELIAC IGA PROFILE
K063818 · MVM
Immunology · 180d
Cleared Apr 11, 2007
QUANTA LITE RNA POL III ELISA
K070066 · NYO
Immunology · 93d
Cleared Apr 04, 2007
QUANTA LITE SS-A 52 ELISA
K063565 · OBE
Immunology · 127d
Cleared Mar 12, 2007
QUANTA LITE H-TTG/DGP SCREEN
K070083 · MST
Immunology · 62d
Cleared Dec 22, 2006
QUANTA LITE INTRINSIC FACTOR ELISA
K061841 · LIG
Immunology · 176d
Cleared Dec 13, 2006
QUANTA LITE CELIAC DGP SCREEN
K062708 · MST
Immunology · 93d
Cleared Oct 18, 2006
QUANTA LITE PBC SCREEN IGG/IGA ELISA
K061842 · NRI
Immunology · 111d
Cleared Nov 23, 2005
QUANTA LITE CCP3 IGG ELISA
K052264 · NHX
Immunology · 96d
Cleared Oct 27, 2005
QUANTA LITE M2 EP (MIT3) ELISA
K052262 · DBM
Immunology · 69d
Cleared Oct 04, 2005
QUANTA LITE GLIADIN IGG II
K052142 · MST
Immunology · 57d

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