bioMerieux, Inc. - FDA 510(k) Cleared Devices
252
Total
251
Cleared
1
Denied
252 devices
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
Sep 02, 2003
VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
Hematology
214d
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
Jun 16, 2003
VIDAS TROPONIN I (TNI), MODEL 30 445
Chemistry
82d
Cleared
Oct 03, 2002
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
Hematology
204d
Cleared
Aug 15, 2002
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
Microbiology
52d
Cleared
Aug 07, 2002
MDA D-DIMER
Hematology
61d
Cleared
Jul 18, 2002
VIDAS TESTOSTERONE (TES), MODEL 30 418
Chemistry
83d
Cleared
Apr 26, 2002
BACT/ALERT SN CULTURE BOTTLE
Microbiology
18d
Cleared
Apr 18, 2002
BACT/ALERT FN CULTURE BOTTLE
Microbiology
36d
Cleared
Apr 18, 2002
BACT/ALERT PF CULTURE BOTTLE
Microbiology
28d
Cleared
Apr 18, 2002
BACT/ALERT SA CULTURE BOTTLE
Microbiology
27d
Cleared
Apr 17, 2002
BACT/ALERT FA CULTURE BOTTLE
Microbiology
35d
Cleared
Mar 29, 2002
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN
Microbiology
91d
Cleared
Mar 25, 2002
VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN
Microbiology
87d
Cleared
Apr 24, 2001
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
Immunology
57d
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