Medical Device Manufacturer · FR , Hauts-De-Seine

Bio-Rad Laboratories

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

Bio-Rad Laboratories — FDA 510(k) Submissions

Bio-Rad Laboratories has submitted 46 FDA 510(k) premarket notifications since 2007, of which 45 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), Enzyme Linked Immunoabsorption Assay, Treponema Pallidum, System, Test, Anticardiolipin Immunological, Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1, System, Test, Vitamin D . Use the specialty filter in the sidebar to narrow results.

46 devices
1–25 of 46
BioPlex 2200 Lyme Total
K183446 · LSR Reagent, Borrelia... · Microbiology
Mar 2019 90d
BioPlex 2200 25-OH Vitamin D Kit
K180577 · MRG System, Test, Vitamin D · Chemistry
Jun 2018 109d
BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
K170509 · PUQ Multiplex Flow... · Microbiology
May 2017 87d
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
K170413 · LIP Enzyme Linked... · Microbiology
May 2017 90d
Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
K163015 · JJY Multi-analyte Controls,... · Immunology
Jan 2017 74d
Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
K152679 · PMN Assayed External Control... · Microbiology
May 2016 235d
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
DEN150058 · PMN Assayed External Control... · Microbiology
Mar 2016 103d
Liquichek Cardiac Markers Plus Control LT
K150300 · JJY Multi-analyte Controls,... · Chemistry
Dec 2015 308d
Liquichek Maternal Serum II Control
K143379 · JJY Multi-analyte Controls,... · Chemistry
Mar 2015 108d
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
K141114 · MRG System, Test, Vitamin D · Chemistry
Jan 2015 254d
LIQUICHEK TUMOR MARKER CONTROL
K141073 · JJY Multi-analyte Controls,... · Immunology
Jun 2014 59d
LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK
K140916 · JJY Multi-analyte Controls,... · Chemistry
May 2014 26d
LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK
K140764 · JJY Multi-analyte Controls,... · Immunology
Apr 2014 29d
LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO
K134013 · JJY Multi-analyte Controls,... · Immunology
Apr 2014 115d
LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
K133960 · JJY Multi-analyte Controls,... · Chemistry
Jan 2014 29d
LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY
K132227 · JJY Multi-analyte Controls,... · Chemistry
Oct 2013 100d
BIOPLEX 2200 APLS IGM
K130528 · MID System, Test,... · Immunology
Oct 2013 234d
LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK
K130761 · JJY Multi-analyte Controls,... · Immunology
Apr 2013 23d
LIQUID ASSAYED MULTIQUAL PREMIUM
K130162 · JJY Multi-analyte Controls,... · Chemistry
Mar 2013 37d
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK
K123775 · JJY Multi-analyte Controls,... · Chemistry
Jan 2013 52d
LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK
K123798 · JJX Single (specified)... · Chemistry
Jan 2013 30d
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK
K123663 · JJY Multi-analyte Controls,... · Chemistry
Dec 2012 29d
LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA
K123198 · JJY Multi-analyte Controls,... · Chemistry
Nov 2012 40d
BIOPLEX 2200 EBV IGM KIT
K123021 · LJN Antibody Igm, If,... · Microbiology
Nov 2012 36d
LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK
K122838 · JJY Multi-analyte Controls,... · Chemistry
Oct 2012 30d
Filters