Medical Device Manufacturer · US , Mchenry , IL

bioMerieux, Inc. - FDA 510(k) Cleared Devices

250 submissions · 249 cleared · Since 1983
250
Total
249
Cleared
1
Denied
205 devices
101-125 of 205
Cleared Aug 14, 2009
VITEK 2 GRAM NEGATIVE MEROPENEM
K091899 · LON
Microbiology · 50d
Cleared Jul 17, 2009
CHROMID MRSA AGAR, MODEL: REF 43 841
K091024 · JSO
Microbiology · 98d
Cleared Jun 18, 2009
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K091126 · LON
Microbiology · 59d
Cleared Mar 16, 2009
VITEK 2 GRAM NEGATIVE DORIPENEM
K082346 · LON
Microbiology · 213d
Cleared Feb 18, 2009
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K083383 · LON
Microbiology · 93d
Cleared Dec 23, 2008
VIDAS RUB IGG
K080766 · LFX
Microbiology · 280d
Cleared Jun 23, 2008
NUCLISENS EASYQ ENTEROVIRUS SYSTEM
K063261 · OAI
Microbiology · 602d
Cleared Jun 11, 2008
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
K080931 · LLH
Microbiology · 70d
Cleared Apr 30, 2008
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
K080201 · LON
Microbiology · 93d
Cleared Feb 28, 2008
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
K080107 · LON
Microbiology · 44d
Cleared Jan 23, 2008
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
K073406 · LON
Microbiology · 50d
Cleared Dec 21, 2007
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
K072138 · LLH
Microbiology · 141d
Cleared Dec 10, 2007
VITEK 2 GRAM NEGATIVE PIPERACILLIN
K073083 · LON
Microbiology · 39d
Cleared Nov 16, 2007
VITEK 2 GRAM POSITIVE TIGECYCLINE
K072695 · LON
Microbiology · 53d
Cleared Oct 15, 2007
VITEK 2 GRAM POSITIVE VANCOMYCIN
K072668 · LON
Microbiology · 24d
Cleared Oct 11, 2007
VIDAS B.R.A.H.M.S. PCT ASSAY
K071146 · NTM
Microbiology · 170d
Cleared Sep 12, 2007
VITEK 2 GRAM NEGATIVE LEVOFLOXACIN
K072038 · LON
Microbiology · 49d
Cleared Jan 19, 2007
VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE
K063597 · LON
Microbiology · 46d
Cleared Jan 11, 2007
VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE
K063623 · LON
Microbiology · 36d
Cleared Dec 21, 2006
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K063492 · LON
Microbiology · 34d
Cleared Sep 19, 2006
VITEK 2 AST-YS FLUCONAZOLE
K061945 · NGZ
Microbiology · 71d
Cleared Jun 20, 2006
VITEK 2 GRAM POSITIVE VRSA SCREEN
K061347 · LON
Microbiology · 36d
Cleared Dec 14, 2005
VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN
K053097 · LON
Microbiology · 41d
Cleared Dec 01, 2005
VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K053186 · LON
Microbiology · 17d
Cleared Nov 07, 2005
VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN
K052656 · LON
Microbiology · 42d

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