Medical Device Manufacturer · US , Chaska , MN

Bio-Rad Laboratories, Inc.

82 submissions · 82 cleared · Since 1991
82
Total
82
Cleared
0
Denied

Bio-Rad Laboratories, Inc. — FDA 510(k) Submissions

Bio-Rad Laboratories, Inc. has submitted 82 FDA 510(k) premarket notifications since 1991, of which 82 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), Assay, Glycosylated Hemoglobin, Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group), System, Test, Radioallergosorbent (rast) Immunological, Drug Mixture Control Materials . Use the specialty filter in the sidebar to narrow results.

82 devices
1–25 of 82
QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
K181661 · OYX Bcr/abl1 Monitoring Test · Medical Genetics
Feb 2019 233d
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
K171664 · GKA Abnormal Hemoglobin... · Hematology
Sep 2017 100d
D-10 Hemoglobin A1c Program
K161687 · PDJ Hemoglobin A1c Test System · Chemistry
Oct 2016 119d
D-100 HbA1c, D-100 HbA1c Calibrator Pack
K151321 · PDJ Hemoglobin A1c Test System · Chemistry
Dec 2015 205d
VARIANT II TURBO HbA1c Kit - 2.0
K142448 · PDJ Hemoglobin A1c Test System · Chemistry
Mar 2015 203d
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
K140801 · LCP Assay, Glycosylated... · Chemistry
Jun 2014 86d
BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI
K130053 · MVM Autoantibodies,... · Immunology
Sep 2013 247d
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK
K130963 · JJY Multi-analyte Controls,... · Chemistry
May 2013 28d
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
K120504 · DIF Drug Mixture Control... · Chemistry
Mar 2012 35d
BIOPLEX 2200 TORC IGG
K120572 · OMI Multiplex Flow... · Microbiology
Mar 2012 28d
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
K120439 · LIP Enzyme Linked... · Microbiology
Mar 2012 30d
MONOLISA ANTI-HAV IGM EIA
K092353 · LOL Hepatitis A Test... · Microbiology
Oct 2009 86d
MONOLISA ANTI-HAV EIA
K092355 · LOL Hepatitis A Test... · Microbiology
Oct 2009 86d
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
K090699 · LCP Assay, Glycosylated... · Chemistry
Jul 2009 132d
HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI
K090737 · JKA Tubes, Vials, Systems,... · Chemistry
Jun 2009 75d
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
K080008 · OMI Multiplex Flow... · Microbiology
Feb 2009 418d
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
K070452 · LCP Assay, Glycosylated... · Chemistry
May 2007 80d
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K062211 · LSE Epstein-barr Virus, Other · Microbiology
Dec 2006 129d
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K062213 · LSE Epstein-barr Virus, Other · Microbiology
Dec 2006 129d
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
K063400 · LCP Assay, Glycosylated... · Chemistry
Dec 2006 22d
D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM
K060001 · LCP Assay, Glycosylated... · Chemistry
Jan 2006 17d
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K043341 · NVI Diagnostic Software,... · Immunology
Oct 2005 328d
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
K051072 · GKA Abnormal Hemoglobin... · Hematology
May 2005 16d
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
K050682 · DIF Drug Mixture Control... · Toxicology
Apr 2005 44d
LIQUICHEK BNP CONTROL
K043584 · JJX Single (specified)... · Chemistry
Feb 2005 42d

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