|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
densicheck plus
|
BIOMERIEUX, INC.
|
K093224 |
11/09/2009
|
densichek plus
|
BIOMERIEUX, INC.
|
K083536 |
09/11/2009
|
gram postitve clindamycin
|
BIOMERIEUX, INC.
|
K122547 |
10/15/2012
|
vitek 2 antimicrobial susceptibility test sytem for sparfloxacin
|
BIOMERIEUX, INC.
|
K020870 |
03/25/2002
|
vitek 2 antimircrobial susceptibility test system for levofloxacin
|
BIOMERIEUX, INC.
|
K020871 |
03/29/2002
|
vitek 2 ast gp ceftaroline
|
BIOMERIEUX, INC.
|
K141149 |
06/20/2014
|
vitek 2 ast gram negative cefotaxime (<=0.25 - >=64 ug/ml)
|
BIOMERIEUX, INC.
|
K161437 |
02/16/2017
|
vitek 2 ast st meropenem
|
BIOMERIEUX, INC.
|
K132507 |
11/15/2013
|
vitek 2 ast st moxifloxacin, vitek 2 ast streptococcus moxifloxacin
|
BIOMERIEUX, INC.
|
K132573 |
09/13/2013
|
vitek 2 ast streptococus vancomycin
|
BIOMERIEUX, INC.
|
K121100 |
11/19/2012
|
|