Bio-Rad Laboratories - FDA 510(k) Cleared Devices
46
Total
45
Cleared
1
Denied
46 devices
Cleared
Jul 09, 2012
ANA-SCREEN WITH MDSS
Immunology
216d
Cleared
Jun 22, 2012
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
Microbiology
84d
Cleared
May 18, 2012
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
Chemistry
32d
Cleared
Mar 30, 2012
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
Immunology
456d
Cleared
Oct 26, 2011
MULTI-ANALYTE DETECTION SYSTEMS
Immunology
29d
Cleared
Aug 23, 2011
BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM,...
Microbiology
127d
Cleared
Dec 03, 2010
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE...
Microbiology
466d
Cleared
Aug 24, 2010
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Immunology
244d
Cleared
Aug 02, 2010
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
Hematology
455d
Cleared
Mar 29, 2010
BIOPLEX 2200 MMRV IGG
Microbiology
299d
Cleared
Mar 12, 2010
LIQUICHEK OPIATE CONTROL
Chemistry
114d
Cleared
Jul 01, 2009
PLATELIA TOXO IGM KIT MODEL 26211
Microbiology
93d
Cleared
May 08, 2009
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION...
Microbiology
79d
Cleared
Sep 08, 2008
LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK
Immunology
53d
Cleared
Jan 24, 2008
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
Chemistry
85d
Cleared
Oct 31, 2007
BIOPLEX VASCULITIS KIT
Immunology
70d
Cleared
Jul 03, 2007
LIQUICHEK TUMOR MARKER CONTROL
Immunology
14d
Cleared
May 03, 2007
MONOLISA ANTI-HAV EIA
Microbiology
182d
Cleared
May 03, 2007
MONOLISA ANTI-HAV IGM EIA
Microbiology
182d
Cleared
Apr 02, 2007
LYPHOCHEK DIABETES CONTROL
Chemistry
35d
Cleared
Mar 19, 2007
BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Microbiology
80d