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
151-175 of 251
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 Sep 02, 2003
VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
K030328 · DAP
Hematology · 214d
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 Jun 16, 2003
VIDAS TROPONIN I (TNI), MODEL 30 445
K030950 · MMI
Chemistry · 82d
Cleared Oct 03, 2002
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
K020810 · DAP
Hematology · 204d
Cleared Aug 15, 2002
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
K022045 · LON
Microbiology · 52d
Cleared Aug 07, 2002
MDA D-DIMER
K021877 · GHH
Hematology · 61d
Cleared Jul 18, 2002
VIDAS TESTOSTERONE (TES), MODEL 30 418
K021326 · CDZ
Chemistry · 83d
Cleared Apr 26, 2002
BACT/ALERT SN CULTURE BOTTLE
K021123 · MDB
Microbiology · 18d
Cleared Apr 18, 2002
BACT/ALERT FN CULTURE BOTTLE
K020815 · MDB
Microbiology · 36d
Cleared Apr 18, 2002
BACT/ALERT PF CULTURE BOTTLE
K020923 · MDB
Microbiology · 28d
Cleared Apr 18, 2002
BACT/ALERT SA CULTURE BOTTLE
K020931 · MDB
Microbiology · 27d
Cleared Apr 17, 2002
BACT/ALERT FA CULTURE BOTTLE
K020813 · MDB
Microbiology · 35d
Cleared Mar 29, 2002
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN
K020871 · LON
Microbiology · 91d
Cleared Mar 25, 2002
VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN
K020870 · LON
Microbiology · 87d
Cleared Apr 24, 2001
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
K010550 · LTJ
Immunology · 57d
Cleared Oct 04, 2000
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
K001460 · LYR
Microbiology · 147d

Looking for a specific device from bioMerieux, Inc.? Search by device name or K-number.

Search all bioMerieux, Inc. devices
Filters