Search FDA 510(k) Database

Cleared Mar 12, 2019

BioPlex 2200 Lyme Total

K183446 · LSR

Bio-Rad Laboratories

Microbiology · 90d

Cleared Feb 13, 2019

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

K181661 · OYX

Bio-Rad Laboratories, Inc.

Medical Genetics · 233d

Cleared Jun 22, 2018

BioPlex 2200 25-OH Vitamin D Kit

K180577 · MRG

Bio-Rad Laboratories

Chemistry · 109d

Cleared Sep 13, 2017

Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview...

K171664 · GKA

Bio-Rad Laboratories, Inc.

Hematology · 100d

Cleared May 19, 2017

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200...

K170509 · PUQ

Bio-Rad Laboratories

Microbiology · 87d

Cleared May 11, 2017

BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR...

K170413 · LIP

Bio-Rad Laboratories

Microbiology · 90d

Cleared Jan 10, 2017

Liquichek Tumor Marker Control-Level 1

K163015 · JJY

Bio-Rad Laboratories

Immunology · 74d

Cleared Oct 14, 2016

D-10 Hemoglobin A1c Program

K161687 · PDJ

Bio-Rad Laboratories, Inc.

Chemistry · 119d

Cleared May 10, 2016

Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek...

K152679 · PMN

Bio-Rad Laboratories

Microbiology · 235d

Not Cleared Mar 28, 2016

Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II,...

DEN150058 · PMN

Bio-Rad Laboratories

Microbiology · 103d

Cleared Dec 11, 2015

Liquichek Cardiac Markers Plus Control LT

K150300 · JJY

Bio-Rad Laboratories

Chemistry · 308d

Cleared Dec 09, 2015

D-100 HbA1c, D-100 HbA1c Calibrator Pack

K151321 · PDJ

Bio-Rad Laboratories, Inc.

Chemistry · 205d

Cleared Mar 24, 2015

VARIANT II TURBO HbA1c Kit - 2.0

K142448 · PDJ

Bio-Rad Laboratories, Inc.

Chemistry · 203d

Cleared Mar 13, 2015

Liquichek Maternal Serum II Control

K143379 · JJY

Bio-Rad Laboratories

Chemistry · 108d

Cleared Jan 09, 2015

BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D...

K141114 · MRG

Bio-Rad Laboratories

Chemistry · 254d

Cleared Jun 25, 2014

VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM

K140801 · LCP

Bio-Rad Laboratories, Inc.

Chemistry · 86d

Cleared Jun 23, 2014

LIQUICHEK TUMOR MARKER CONTROL

K141073 · JJY

Bio-Rad Laboratories

Immunology · 59d

Cleared May 06, 2014

LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK

K140916 · JJY

Bio-Rad Laboratories

Chemistry · 26d

Cleared Apr 25, 2014

LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK

K140764 · JJY

Bio-Rad Laboratories

Immunology · 29d

Cleared Apr 24, 2014

LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL,...

K134013 · JJY

Bio-Rad Laboratories

Immunology · 115d

Cleared Jan 22, 2014

LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL

K133960 · JJY

Bio-Rad Laboratories

Chemistry · 29d

Cleared Oct 25, 2013

LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM...

K132227 · JJY

Bio-Rad Laboratories

Chemistry · 100d

Cleared Oct 21, 2013

BIOPLEX 2200 APLS IGM

K130528 · MID

Bio-Rad Laboratories

Immunology · 234d

Cleared Sep 19, 2013

BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200...

K130053 · MVM

Bio-Rad Laboratories, Inc.

Immunology · 247d