Inova Diagnostics, Inc. - FDA 510(k) Cleared Devices
138
Total
136
Cleared
2
Denied
138 devices
Cleared
Nov 04, 1998
QUANTA LITE H. PYLORI IGG ELISA
Microbiology
86d
Cleared
Nov 04, 1998
QUANTA LITE RF IGG ELISA
Immunology
62d
Cleared
Nov 04, 1998
QUANTA LITE RF IGA ELISA
Immunology
62d
Cleared
Oct 07, 1998
QUANTA LITE CHROMATIN ELISA
Immunology
72d
Cleared
Sep 04, 1998
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
Immunology
87d
Cleared
Aug 27, 1998
QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA
Immunology
51d
Cleared
Jul 29, 1998
QUANTA LITE TPO ELISA
Immunology
63d
Cleared
Jun 19, 1998
QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT
Immunology
67d
Cleared
Jun 19, 1998
QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT
Immunology
67d
Cleared
Jun 05, 1998
QUANTA LITE RIBOSOME P ELISA
Immunology
63d
Cleared
Apr 02, 1998
NOVA LITE ENDOMYSIAL
Immunology
65d
Cleared
Mar 24, 1998
QUANTA LITE B2 GPI SCREEN
Immunology
61d
Cleared
Jan 02, 1998
QUANTA LITE REBELLA IGG
Microbiology
269d
Cleared
Dec 02, 1997
QUANTA LITE TOXOPLASMA IGG
Microbiology
228d
Cleared
Dec 01, 1997
QUANTA LITE CMV IGG ELISA
Microbiology
235d
Cleared
Oct 20, 1997
QUANTA LITE B2 GPI IGA
Immunology
68d
Cleared
Oct 20, 1997
QUANTA LITE B2GPI IGM
Immunology
68d
Cleared
Jul 22, 1997
QUANTA LITE RUBEOLA (MEASLES) IGG
Microbiology
82d
Cleared
Jun 24, 1997
QUANTA LITE B2GPI IGG
Immunology
132d
Cleared
Jun 20, 1997
QUANTA LITE RF IGM
Immunology
49d
Cleared
Jun 02, 1997
QUANTA LITE IGA GLIADIN ELISA
Immunology
171d
Cleared
May 30, 1997
QUANTA LITE IGG GLIADIN ELISA
Immunology
168d
Cleared
Jul 10, 1996
NOVA LITE ANCA
Immunology
107d
Cleared
Jul 10, 1996
QUANTA LITE ENA 6 ELISA
Immunology
54d
Cleared
Mar 19, 1996
QUANTA LITE PR3
Immunology
138d
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