Inova Diagnostics, Inc. - FDA 510(k) Cleared Devices
138
Total
136
Cleared
2
Denied
129 devices
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
Oct 20, 1997
QUANTA LITE B2 GPI IGA
Immunology
68d
Cleared
Oct 20, 1997
QUANTA LITE B2GPI IGM
Immunology
68d
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
Cleared
Mar 19, 1996
QUANTA LITE MPO
Immunology
138d
Cleared
Feb 29, 1996
QUANTA LITE SSDNA
Immunology
163d
Cleared
Sep 01, 1995
QUANTA LITE IGA ACA (HRP)
Immunology
45d
Cleared
Aug 29, 1995
QUANTA LITE ACA SCREEN (HRP)
Immunology
46d
Cleared
Jul 18, 1995
QUANTA LITE(TM) IGG (HRP)
Immunology
221d
Cleared
Jul 18, 1995
QUANTA LITE ACA IGM (HRP)
Immunology
221d
Cleared
Oct 25, 1994
QUANTA LITE ENA 5 ELISA KIT
Immunology
119d
Cleared
Dec 21, 1993
QUANTA LITE(TM) HISTONE ELISA
Immunology
124d
Cleared
Aug 05, 1993
QUANTA LITE MITOCHONDRIA M2 ELISA
Immunology
36d
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