Medical Device Manufacturer · FR , Hauts-De-Seine

Bio-Rad Laboratories - FDA 510(k) Cleared Devices

46 submissions · 45 cleared · Since 2007
46
Total
45
Cleared
1
Denied

FDA 510(k) cleared devices by Bio-Rad Laboratories Chemistry

17 devices
1-17 of 17
Cleared Jun 22, 2018
BioPlex 2200 25-OH Vitamin D Kit
K180577 · MRG
Chemistry · 109d
Cleared Dec 11, 2015
Liquichek Cardiac Markers Plus Control LT
K150300 · JJY
Chemistry · 308d
Cleared Mar 13, 2015
Liquichek Maternal Serum II Control
K143379 · JJY
Chemistry · 108d
Cleared Jan 09, 2015
BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D...
K141114 · MRG
Chemistry · 254d
Cleared May 06, 2014
LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK
K140916 · JJY
Chemistry · 26d
Cleared Jan 22, 2014
LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
K133960 · JJY
Chemistry · 29d
Cleared Oct 25, 2013
LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM...
K132227 · JJY
Chemistry · 100d
Cleared Mar 01, 2013
LIQUID ASSAYED MULTIQUAL PREMIUM
K130162 · JJY
Chemistry · 37d
Cleared Jan 31, 2013
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL...
K123775 · JJY
Chemistry · 52d
Cleared Jan 09, 2013
LIQUIDCHEK DIABETES CONTROL
K123798 · JJX
Chemistry · 30d
Cleared Dec 27, 2012
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT
K123663 · JJY
Chemistry · 29d
Cleared Nov 20, 2012
LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK...
K123198 · JJY
Chemistry · 40d
Cleared Oct 17, 2012
LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY...
K122838 · JJY
Chemistry · 30d
Cleared May 18, 2012
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
K121143 · DIF
Chemistry · 32d
Cleared Mar 12, 2010
LIQUICHEK OPIATE CONTROL
K093577 · DIF
Chemistry · 114d
Cleared Jan 24, 2008
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
K073080 · JJY
Chemistry · 85d
Cleared Apr 02, 2007
LYPHOCHEK DIABETES CONTROL
K070546 · GGM
Chemistry · 35d
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