bioMerieux, Inc. - FDA 510(k) Cleared Devices
251
Total
250
Cleared
1
Denied
251 devices
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
Cleared
Oct 04, 2000
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
Microbiology
147d
Looking for a specific device from bioMerieux, Inc.? Search by device name or K-number.
Search all bioMerieux, Inc. devices