bioMerieux, Inc. - FDA 510(k) Cleared Devices
250
Total
249
Cleared
1
Denied
205 devices
Cleared
Oct 12, 2012
ETEST CEFTAROLINE
Microbiology
193d
Cleared
Aug 28, 2012
VITEK 2 STRPTOCOCCUS CEFTRIAXONE
Microbiology
25d
Cleared
Aug 16, 2012
VITEK 2 AST-ST CEFOTAXIME
Microbiology
51d
Cleared
Aug 07, 2012
VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE
Microbiology
229d
Cleared
Jun 29, 2012
VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM
Microbiology
242d
Cleared
Feb 28, 2012
VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE
Microbiology
238d
Cleared
Feb 17, 2012
VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
Microbiology
220d
Cleared
Feb 10, 2012
VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE
Microbiology
93d
Cleared
Nov 30, 2011
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
Microbiology
321d
Cleared
Oct 26, 2011
VITEK 2 STREPTOCOCCUS PENICILLIN
Microbiology
105d
Cleared
Oct 18, 2011
VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
Microbiology
105d
Cleared
Oct 14, 2011
VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
Microbiology
295d
Cleared
Oct 03, 2011
VITEK 2 STREPTOCOCCUS LEVOFLOXACIN
Microbiology
61d
Cleared
Sep 27, 2011
VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
Microbiology
63d
Cleared
Sep 15, 2011
VITEK 2 STRPTOCOCCUS AMPICILLIN
Microbiology
57d
Cleared
Aug 12, 2011
VITEK 2 AST-ST LINEZOLID
Microbiology
65d
Cleared
May 20, 2011
NUCLISENS EASYQ MRSA
Microbiology
240d
Cleared
May 18, 2011
VIDAS TOXO IGG AVIDITY
Microbiology
310d
Cleared
Oct 21, 2010
VITEK 2 GRAM POSITIVE DOXCYCLINE
Microbiology
386d
Cleared
Sep 28, 2010
VITEK 2 YEAST CASPOFUNGIN
Microbiology
116d
Cleared
Jul 06, 2010
NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS...
Microbiology
249d
Cleared
May 21, 2010
VITEK 2 YEAST VORICONAZOLE
Microbiology
284d
Cleared
Mar 02, 2010
CHROMID VRE AGAR, MODEL: REF 43 851
Microbiology
326d
Cleared
Nov 09, 2009
DENSICHECK PLUS
Microbiology
26d
Cleared
Sep 11, 2009
DENSICHEK PLUS
Microbiology
287d
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