FDA 510(k) Applications Submitted by BIO-RAD LABORATORIES
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K170509 |
02/21/2017 |
BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set |
Bio-Rad Laboratories |
| K180577 |
03/05/2018 |
BioPlex 2200 25-OH Vitamin D Kit |
Bio-Rad Laboratories |
| K183446 |
12/12/2018 |
BioPlex 2200 Lyme Total |
Bio-Rad Laboratories |
| K091616 |
06/03/2009 |
BIOPLEX 2200 MMRV IGG |
Bio-Rad Laboratories |
| K063866 |
12/29/2006 |
BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
Bio-Rad Laboratories |
| K090409 |
02/18/2009 |
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
Bio-Rad Laboratories |
| K150300 |
02/06/2015 |
Liquichek Cardiac Markers Plus Control LT |
Bio-Rad Laboratories |
| K070546 |
02/26/2007 |
LYPHOCHEK DIABETES CONTROL |
Bio-Rad Laboratories |
| K082036 |
07/17/2008 |
LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK |
Bio-Rad Laboratories |
| K152679 |
09/18/2015 |
Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak |
BIO-RAD LABORATORIES |
| K163015 |
10/28/2016 |
Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak |
BIO-RAD LABORATORIES |
| K093577 |
11/18/2009 |
LIQUICHEK OPIATE CONTROL |
Bio-Rad Laboratories |
| K143379 |
11/25/2014 |
Liquichek Maternal Serum II Control |
Bio-Rad Laboratories |
| DEN150058 |
12/16/2015 |
Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak |
Bio-Rad Laboratories |
| K170413 |
02/10/2017 |
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set |
Bio-Rad Laboratories |
| K130528 |
03/01/2013 |
BIOPLEX 2200 APLS IGM |
Bio-Rad Laboratories |
| K120959 |
03/30/2012 |
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT |
Bio-Rad Laboratories |
| K111072 |
04/18/2011 |
BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL |
Bio-Rad Laboratories |
| K141114 |
04/30/2014 |
BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D |
Bio-Rad Laboratories |
| K112810 |
09/27/2011 |
MULTI-ANALYTE DETECTION SYSTEMS |
Bio-Rad Laboratories |
| K123021 |
09/27/2012 |
BIOPLEX 2200 EBV IGM KIT |
Bio-Rad Laboratories |
| K113610 |
12/06/2011 |
ANA-SCREEN WITH MDSS |
Bio-Rad Laboratories |
| K093954 |
12/23/2009 |
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
Bio-Rad Laboratories |
| K103834 |
12/30/2010 |
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS |
Bio-Rad Laboratories |
| K063318 |
11/02/2006 |
MONOLISA ANTI-HAV EIA |
Bio-Rad Laboratories |
| K063319 |
11/02/2006 |
MONOLISA ANTI-HAV IGM EIA |
Bio-Rad Laboratories |
| K071675 |
06/19/2007 |
LIQUICHEK TUMOR MARKER CONTROL |
Bio-Rad Laboratories |
| K073080 |
10/31/2007 |
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 |
Bio-Rad Laboratories |
| K092587 |
08/24/2009 |
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM |
Bio-Rad Laboratories |
| K090847 |
03/30/2009 |
PLATELIA TOXO IGM KIT MODEL 26211 |
Bio-Rad Laboratories |
| K072358 |
08/22/2007 |
BIOPLEX VASCULITIS KIT |
Bio-Rad Laboratories |
| K130162 |
01/23/2013 |
LIQUID ASSAYED MULTIQUAL PREMIUM |
Bio-Rad Laboratories |
| K130761 |
03/20/2013 |
LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK |
Bio-Rad Laboratories |
| K140764 |
03/27/2014 |
LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK |
Bio-Rad Laboratories |
| K140916 |
04/10/2014 |
LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK |
Bio-Rad Laboratories |
| K141073 |
04/25/2014 |
LIQUICHEK TUMOR MARKER CONTROL |
Bio-Rad Laboratories |
| K132227 |
07/17/2013 |
LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY |
Bio-Rad Laboratories |
| K122838 |
09/17/2012 |
LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK |
Bio-Rad Laboratories |
| K123198 |
10/11/2012 |
LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA |
Bio-Rad Laboratories |
| K123663 |
11/28/2012 |
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK |
Bio-Rad Laboratories |
| K123775 |
12/10/2012 |
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK |
Bio-Rad Laboratories |
| K123798 |
12/10/2012 |
LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK |
Bio-Rad Laboratories |
| K133960 |
12/24/2013 |
LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL |
Bio-Rad Laboratories |
| K134013 |
12/30/2013 |
LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO |
Bio-Rad Laboratories |
| K091303 |
05/04/2009 |
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV |
Bio-Rad Laboratories |
| K121143 |
04/16/2012 |
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) |
Bio-Rad Laboratories |
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