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
126-150 of 205
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 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 08, 2004
VITEK 2 ESBL TEST
K040845 · LON
Microbiology · 68d
Cleared Nov 12, 2003
VITEK 2 GRAM NEGATIVE MOXIFLOXACIN
K032861 · LON
Microbiology · 61d
Cleared Nov 04, 2003
VITEK 2 GRAM NEGATIVE GATIFLOXACIN
K032788 · LON
Microbiology · 57d
Cleared Oct 31, 2003
VITEK GRAM NEGATIVE GATIFLOXACIN
K032711 · LON
Microbiology · 59d
Cleared Oct 31, 2003
VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN
K032738 · LON
Microbiology · 57d
Cleared Oct 31, 2003
VITEK 2 GRAM POSITIVE LINEZOLID
K032766 · LON
Microbiology · 56d
Cleared Sep 10, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN
K032399 · LON
Microbiology · 37d
Cleared Aug 22, 2003
VITEK 2 GRAM POSITIVE GATIFLOXACIN
K032314 · LON
Microbiology · 25d
Cleared Aug 13, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE
K031865 · LON
Microbiology · 57d
Cleared Jul 14, 2003
BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
K031737 · MDB
Microbiology · 40d
Cleared Jul 10, 2003
VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE
K031410 · LON
Microbiology · 66d
Cleared Aug 15, 2002
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
K022045 · LON
Microbiology · 52d
Cleared Apr 26, 2002
BACT/ALERT SN CULTURE BOTTLE
K021123 · MDB
Microbiology · 18d

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