Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

134 results for "Bio-Rad Laboratories"
1–24 of 134
Search insights Median review: 80d Cleared: 99% Top manufacturer: Bio-Rad Laboratories, Inc. Lead specialty: Chemistry
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