FDA 510(k) Applications Submitted by Nancy Weaver
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| DEN130013 |
01/02/2013 |
VITEK MS |
BIOMERIEUX, INC. |
| K050002 |
01/03/2005 |
VITEK 2 COMPACT |
BIOMERIEUX, INC. |
| K080107 |
01/15/2008 |
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM |
BIOMERIEUX, INC. |
| K010550 |
02/26/2001 |
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 |
BIOMERIEUX, INC. |
| K030950 |
03/26/2003 |
VIDAS TROPONIN I (TNI), MODEL 30 445 |
BIOMERIEUX, INC. |
| K040845 |
04/01/2004 |
VITEK 2 ESBL TEST |
BIOMERIEUX, INC. |
| K091024 |
04/10/2009 |
CHROMID MRSA AGAR, MODEL: REF 43 841 |
BIOMERIEUX, INC. |
| K091025 |
04/10/2009 |
CHROMID VRE AGAR, MODEL: REF 43 851 |
BIOMERIEUX, INC. |
| K050976 |
04/18/2005 |
VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE |
BIOMERIEUX, INC. |
| K031410 |
05/05/2003 |
VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
| K061347 |
05/15/2006 |
VITEK 2 GRAM POSITIVE VRSA SCREEN |
BIOMERIEUX, INC. |
| K101566 |
06/04/2010 |
VITEK 2 YEAST CASPOFUNGIN |
BIOMERIEUX, INC. |
| K031865 |
06/17/2003 |
VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
| K022045 |
06/24/2002 |
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID |
BIOMERIEUX, INC. |
| K091899 |
06/25/2009 |
VITEK 2 GRAM NEGATIVE MEROPENEM |
BIOMERIEUX, INC. |
| K051849 |
07/07/2005 |
VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
| K061945 |
07/10/2006 |
VITEK 2 AST-YS FLUCONAZOLE |
BIOMERIEUX, INC. |
| K041982 |
07/23/2004 |
VITEK 2 GRAM NEGATIVE ERTAPENEM |
BIOMERIEUX, INC. |
| K032314 |
07/28/2003 |
VITEK 2 GRAM POSITIVE GATIFLOXACIN |
BIOMERIEUX, INC. |
| K032399 |
08/04/2003 |
VITEK 2 GRAM POSITIVE MOXIFLOXACIN |
BIOMERIEUX, INC. |
| K092454 |
08/10/2009 |
VITEK 2 YEAST VORICONAZOLE |
BIOMERIEUX, INC. |
| K032711 |
09/02/2003 |
VITEK GRAM NEGATIVE GATIFLOXACIN |
BIOMERIEUX, INC. |
| K032738 |
09/04/2003 |
VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN |
BIOMERIEUX, INC. |
| K032766 |
09/05/2003 |
VITEK 2 GRAM POSITIVE LINEZOLID |
BIOMERIEUX, INC. |
| K032788 |
09/08/2003 |
VITEK 2 GRAM NEGATIVE GATIFLOXACIN |
BIOMERIEUX, INC. |
| K032861 |
09/12/2003 |
VITEK 2 GRAM NEGATIVE MOXIFLOXACIN |
BIOMERIEUX, INC. |
| K073083 |
11/01/2007 |
VITEK 2 GRAM NEGATIVE PIPERACILLIN |
BIOMERIEUX, INC. |
| K053097 |
11/03/2005 |
VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN |
BIOMERIEUX, INC. |
| K053186 |
11/14/2005 |
VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
| K073406 |
12/04/2007 |
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE |
BIOMERIEUX, INC. |
| K020870 |
12/28/2001 |
VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN |
BIOMERIEUX, INC. |
| K020871 |
12/28/2001 |
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN |
BIOMERIEUX, INC. |
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