bioMerieux, Inc. - FDA 510(k) Cleared Devices
250
Total
249
Cleared
1
Denied
205 devices
Cleared
Sep 29, 2005
VITEK 2 GRAM NEGATIVE TIGECYCLINE
Microbiology
36d
Cleared
Aug 16, 2005
VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE
Microbiology
40d
Cleared
May 23, 2005
VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
Microbiology
35d
Cleared
May 12, 2005
VITEK 2 GRAM POSITIVE MEROPENEM
Microbiology
42d
Cleared
Feb 28, 2005
VITEK 2 GRAM POSITIVE DAPTOMYCIN
Microbiology
47d
Cleared
Feb 18, 2005
VITEK 2 GRAM POSITIVE ERTAPENEM
Microbiology
37d
Cleared
Feb 17, 2005
VITEK 2 COMPACT
Microbiology
45d
Cleared
Dec 30, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM
Microbiology
38d
Cleared
Dec 23, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN
Microbiology
31d
Cleared
Dec 13, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM
Microbiology
47d
Cleared
Dec 07, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN
Microbiology
42d
Cleared
Sep 14, 2004
VITEK 2 GRAM NEGATIVE ERTAPENEM
Microbiology
53d
Cleared
Jun 08, 2004
VITEK 2 ESBL TEST
Microbiology
68d
Cleared
Nov 12, 2003
VITEK 2 GRAM NEGATIVE MOXIFLOXACIN
Microbiology
61d
Cleared
Nov 04, 2003
VITEK 2 GRAM NEGATIVE GATIFLOXACIN
Microbiology
57d
Cleared
Oct 31, 2003
VITEK GRAM NEGATIVE GATIFLOXACIN
Microbiology
59d
Cleared
Oct 31, 2003
VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN
Microbiology
57d
Cleared
Oct 31, 2003
VITEK 2 GRAM POSITIVE LINEZOLID
Microbiology
56d
Cleared
Sep 10, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN
Microbiology
37d
Cleared
Aug 22, 2003
VITEK 2 GRAM POSITIVE GATIFLOXACIN
Microbiology
25d
Cleared
Aug 13, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE
Microbiology
57d
Cleared
Jul 14, 2003
BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
Microbiology
40d
Cleared
Jul 10, 2003
VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE
Microbiology
66d
Cleared
Aug 15, 2002
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
Microbiology
52d
Cleared
Apr 26, 2002
BACT/ALERT SN CULTURE BOTTLE
Microbiology
18d
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