bioMerieux, Inc. - FDA 510(k) Cleared Devices
250
Total
249
Cleared
1
Denied
205 devices
Cleared
Feb 13, 2017
VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)
Microbiology
257d
Cleared
Feb 01, 2017
VITEK 2 AST-GN Tobramycin (/= 16 ug/mL)
Microbiology
90d
Cleared
Jan 27, 2017
chromID Strepto B agar
Microbiology
88d
Cleared
Jan 24, 2017
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
Microbiology
88d
Cleared
Jan 12, 2017
VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
Microbiology
258d
Cleared
Oct 25, 2016
chromID MRSA
Microbiology
90d
Cleared
Jul 20, 2016
VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
Microbiology
79d
Cleared
Jun 28, 2016
VIDAS B.R.A.H.M.S. PCT (PCT)
Microbiology
88d
Cleared
Apr 15, 2016
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)
Microbiology
263d
Cleared
Mar 25, 2016
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)
Microbiology
256d
Cleared
Mar 11, 2016
chromID MRSA
Microbiology
262d
Cleared
Feb 18, 2016
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL
Microbiology
227d
Cleared
Aug 19, 2014
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE
Microbiology
239d
Cleared
Aug 05, 2014
VITEK 2 AST - YEAST FLUCONAZOLE
Microbiology
232d
Cleared
Jun 20, 2014
VITEK 2 AST GP CEFTAROLINE
Microbiology
46d
Cleared
Nov 15, 2013
VITEK 2 AST ST MEROPENEM
Microbiology
95d
Cleared
Oct 10, 2013
VITEK 2 AST-ST TIGECYCLINE
Microbiology
115d
Cleared
Sep 13, 2013
VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
Microbiology
28d
Not Cleared
Aug 21, 2013
VITEK MS
Microbiology
231d
Cleared
Jan 25, 2013
BACT/ALERT PF PLUS CULTURE BOTTLE
Microbiology
255d
Cleared
Jan 25, 2013
BACT/ALERT FN PLUS CULTURE BOTTLE
Microbiology
254d
Cleared
Jan 22, 2013
BACT/ALERT FA PLUS CULTURE BOTTLE
Microbiology
250d
Cleared
Nov 20, 2012
VITEK 2 GRAM NEGATIVE DOXYCYCLINE
Microbiology
179d
Cleared
Nov 19, 2012
VITEK 2 AST STREPTOCOCUS VANCOMYCIN
Microbiology
222d
Cleared
Oct 15, 2012
GRAM POSTITVE CLINDAMYCIN
Microbiology
55d
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