FDA 510(k) Applications Submitted by BRYS C MYERS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K070066 |
01/08/2007 |
QUANTA LITE RNA POL III ELISA |
INOVA DIAGNOSTICS, INC. |
| K070083 |
01/09/2007 |
QUANTA LITE H-TTG/DGP SCREEN |
INOVA DIAGNOSTICS, INC. |
| K980230 |
01/22/1998 |
QUANTA LITE B2 GPI SCREEN |
INOVA DIAGNOSTICS, INC. |
| K040160 |
01/23/2004 |
QUANTA PLEX SLE PROFILE 8 |
INOVA DIAGNOSTICS, INC. |
| K980312 |
01/27/1998 |
NOVA LITE ENDOMYSIAL |
INOVA DIAGNOSTICS, INC. |
| K020414 |
02/07/2002 |
QUANTA LITE CCP ELISA |
INOVA DIAGNOSTICS, INC. |
| K970551 |
02/12/1997 |
QUANTA LITE B2GPI IGG |
INOVA DIAGNOSTICS, INC. |
| K010558 |
02/26/2001 |
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA |
INOVA DIAGNOSTICS, INC. |
| K030681 |
03/05/2003 |
QUANTA PLEX ENA PROFILE 5 |
INOVA DIAGNOSTICS, INC. |
| K000733 |
03/06/2000 |
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA |
INOVA DIAGNOSTICS, INC. |
| K050715 |
03/18/2005 |
QUANTA PLEX ANCA PROFILE |
INOVA DIAGNOSTICS, INC. |
| K961340 |
03/25/1996 |
NOVA LITE ANCA |
INOVA DIAGNOSTICS, INC. |
| K981237 |
04/03/1998 |
QUANTA LITE RIBOSOME P ELISA |
INOVA DIAGNOSTICS, INC. |
| K971304 |
04/08/1997 |
QUANTA LITE REBELLA IGG |
INOVA DIAGNOSTICS, INC. |
| K971335 |
04/10/1997 |
QUANTA LITE CMV IGG ELISA |
INOVA DIAGNOSTICS, INC. |
| K981330 |
04/13/1998 |
QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT |
INOVA DIAGNOSTICS, INC. |
| K981328 |
04/13/1998 |
QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT |
INOVA DIAGNOSTICS, INC. |
| K011140 |
04/13/2001 |
QUANTA PLEX ENA PROFILE 4 |
INOVA DIAGNOSTICS, INC. |
| K971441 |
04/18/1997 |
QUANTA LITE TOXOPLASMA IGG |
INOVA DIAGNOSTICS, INC. |
| K971620 |
05/01/1997 |
QUANTA LITE RUBEOLA (MEASLES) IGG |
INOVA DIAGNOSTICS, INC. |
| K971614 |
05/02/1997 |
QUANTA LITE RF IGM |
INOVA DIAGNOSTICS, INC. |
| K031450 |
05/07/2003 |
QUANTA PLEX ENA PROFILE 6 |
INOVA DIAGNOSTICS, INC. |
| K021482 |
05/08/2002 |
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA |
INOVA DIAGNOSTICS, INC. |
| K991657 |
05/13/1999 |
QUANTA LITE ANA ELISA |
INOVA DIAGNOSTICS, INC. |
| K961913 |
05/17/1996 |
QUANTA LITE ENA 6 ELISA |
INOVA DIAGNOSTICS, INC. |
| K021648 |
05/20/2002 |
QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA |
INOVA DIAGNOSTICS, INC. |
| K011566 |
05/21/2001 |
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA |
INOVA DIAGNOSTICS, INC. |
| K011570 |
05/21/2001 |
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA |
INOVA DIAGNOSTICS, INC. |
| K981857 |
05/27/1998 |
QUANTA LITE TPO ELISA |
INOVA DIAGNOSTICS, INC. |
| K982023 |
06/09/1998 |
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT |
INOVA DIAGNOSTICS, INC. |
| K982366 |
07/07/1998 |
QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA |
INOVA DIAGNOSTICS, INC. |
| DEN000007 |
07/18/2000 |
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA |
INOVA DIAGNOSTICS, INC. |
| K982603 |
07/27/1998 |
QUANTA LITE CHROMATIN ELISA |
INOVA DIAGNOSTICS, INC. |
| K052142 |
08/08/2005 |
QUANTA LITE GLIADIN IGG II |
INOVA DIAGNOSTICS, INC. |
| K052143 |
08/08/2005 |
QUANTA LITE GLIADIN IGA II |
INOVA DIAGNOSTICS, INC. |
| K982790 |
08/10/1998 |
QUANTA LITE H. PYLORI IGG ELISA |
INOVA DIAGNOSTICS, INC. |
| K973006 |
08/13/1997 |
QUANTA LITE B2 GPI IGA |
INOVA DIAGNOSTICS, INC. |
| K973014 |
08/13/1997 |
QUANTA LITE B2GPI IGM |
INOVA DIAGNOSTICS, INC. |
| K052264 |
08/19/2005 |
QUANTA LITE CCP3 IGG ELISA |
INOVA DIAGNOSTICS, INC. |
| K052262 |
08/19/2005 |
QUANTA LITE M2 EP (MIT3) ELISA |
INOVA DIAGNOSTICS, INC. |
| K983083 |
09/03/1998 |
QUANTA LITE RF IGG ELISA |
INOVA DIAGNOSTICS, INC. |
| K983084 |
09/03/1998 |
QUANTA LITE RF IGA ELISA |
INOVA DIAGNOSTICS, INC. |
| K072632 |
09/18/2007 |
QUANTA PLEX CELIAC IGG PROFILE |
INOVA DIAGNOSTICS, INC. |
| K954380 |
09/19/1995 |
QUANTA LITE SSDNA |
INOVA DIAGNOSTICS, INC. |
| K072967 |
10/22/2007 |
QUANTA LITE F-ACTIN IGA ELISA |
INOVA DIAGNOSTICS, INC. |
| K955022 |
11/02/1995 |
QUANTA LITE MPO |
INOVA DIAGNOSTICS, INC. |
| K955021 |
11/02/1995 |
QUANTA LITE PR3 |
INOVA DIAGNOSTICS, INC. |
| K984137 |
11/18/1998 |
QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA |
INOVA DIAGNOSTICS, INC. |
| K984222 |
11/25/1998 |
QUANTA LITE LYME IGG ELISA |
INOVA DIAGNOSTICS, INC. |
| K984234 |
11/25/1998 |
QUANTA LITE LYME IGM ELISA |
INOVA DIAGNOSTICS, INC. |
| K063565 |
11/28/2006 |
QUANTA LITE SS-A 52 ELISA |
INOVA DIAGNOSTICS, INC. |
| K984336 |
12/03/1998 |
QUANTA LITE GBM ELISA |
INOVA DIAGNOSTICS, INC. |
| K964985 |
12/13/1996 |
QUANTA LITE IGG GLIADIN ELISA |
INOVA DIAGNOSTICS, INC. |
| K964986 |
12/13/1996 |
QUANTA LITE IGA GLIADIN ELISA |
INOVA DIAGNOSTICS, INC. |
| K063818 |
12/22/2006 |
QUANTA PLEX CELIAC IGA PROFILE |
INOVA DIAGNOSTICS, INC. |
| K024334 |
12/26/2002 |
QUANTA LITE H.PYLORI IGA ELISA |
INOVA DIAGNOSTICS, INC. |
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