Inova Diagnostics, Inc. - FDA 510(k) Cleared Devices
138
Total
136
Cleared
2
Denied
138 devices
Cleared
Oct 04, 2005
QUANTA LITE GLIADIN IGA II
Immunology
57d
Cleared
Jun 13, 2005
QUANTA LITE SP100 ELISA
Immunology
90d
Cleared
May 12, 2005
QUANTA PLEX ANCA PROFILE
Immunology
55d
Cleared
Jun 25, 2004
QUANTA LITE GP210 ELISA
Immunology
81d
Cleared
Mar 08, 2004
QUANTA PLEX SLE PROFILE 8
Immunology
45d
Cleared
Jun 25, 2003
QUANTA PLEX ENA PROFILE 6
Immunology
49d
Cleared
Apr 24, 2003
QUANTA PLEX ENA PROFILE 5
Immunology
50d
Cleared
Mar 27, 2003
QUANTA LITE H.PYLORI IGA ELISA
Microbiology
91d
Cleared
Sep 20, 2002
QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
Immunology
123d
Cleared
Jul 30, 2002
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
Immunology
83d
Cleared
Apr 29, 2002
QUANTA LITE CCP ELISA
Immunology
81d
Cleared
Jul 27, 2001
QUANTA PLEX ENA PROFILE 4
Immunology
105d
Cleared
Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
Immunology
49d
Cleared
Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
Immunology
49d
Cleared
May 21, 2001
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
Immunology
441d
Cleared
Apr 03, 2001
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
Immunology
36d
Cleared
Jan 22, 2001
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA
Immunology
32d
Not Cleared
Aug 16, 2000
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
Immunology
29d
Cleared
Jun 07, 2000
QUANTA LITE LKM-1 ELISA
Immunology
111d
Cleared
Jan 27, 2000
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
Microbiology
64d
Cleared
Jun 17, 1999
QUANTA LITE ANA ELISA
Immunology
35d
Cleared
Apr 15, 1999
QUANTA LITE LYME IGG ELISA
Microbiology
141d
Cleared
Apr 15, 1999
QUANTA LITE LYME IGM ELISA
Microbiology
141d
Cleared
Feb 08, 1999
QUANTA LITE GBM ELISA
Immunology
67d
Cleared
Jan 28, 1999
QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA
Immunology
71d
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