Medical Device Manufacturer · US , Mchenry , IL

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

251 submissions · 250 cleared · Since 1983
251
Total
250
Cleared
1
Denied
251 devices
126-150 of 251
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 23, 2005
COAG-A-MATE MTX III
K051030 · JPA
Hematology · 245d
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
Cleared Sep 29, 2005
VITEK 2 GRAM NEGATIVE TIGECYCLINE
K052311 · LON
Microbiology · 36d
Cleared Aug 16, 2005
VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE
K051849 · LON
Microbiology · 40d
Cleared May 23, 2005
VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
K050976 · LON
Microbiology · 35d
Cleared May 12, 2005
VITEK 2 GRAM POSITIVE MEROPENEM
K050816 · LON
Microbiology · 42d
Cleared Apr 01, 2005
MDA B.30
K050513 · JPA
Hematology · 31d
Cleared Feb 28, 2005
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K050075 · LON
Microbiology · 47d
Cleared Feb 18, 2005
VITEK 2 GRAM POSITIVE ERTAPENEM
K050076 · LON
Microbiology · 37d
Cleared Feb 17, 2005
VITEK 2 COMPACT
K050002 · LON
Microbiology · 45d
Cleared Dec 30, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM
K043230 · LON
Microbiology · 38d
Cleared Dec 23, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN
K043237 · LON
Microbiology · 31d
Cleared Dec 13, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM
K042963 · LON
Microbiology · 47d
Cleared Dec 07, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN
K042946 · LON
Microbiology · 42d
Cleared Sep 14, 2004
VITEK 2 GRAM NEGATIVE ERTAPENEM
K041982 · LON
Microbiology · 53d
Cleared Jun 10, 2004
VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
K040882 · DAP
Hematology · 66d
Cleared Jun 08, 2004
VITEK 2 ESBL TEST
K040845 · LON
Microbiology · 68d

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