Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

85 results for "Bio-Rad Laboratories, Inc."
1–24 of 85
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 Sep 13, 2017
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview...
K171664 · GKA
Bio-Rad Laboratories, Inc.
Hematology · 100d
Cleared Oct 14, 2016
D-10 Hemoglobin A1c Program
K161687 · PDJ
Bio-Rad Laboratories, Inc.
Chemistry · 119d
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 Jun 25, 2014
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
K140801 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 86d
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
Cleared May 09, 2013
VARIANT(TM) II TURBO HBA1C KIT - 2.0
K130990 · LCP
Bio-Rad Laboratories, Inc., Clinical...
Chemistry · 29d
Cleared May 06, 2013
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1
K130963 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 28d
Cleared Apr 25, 2013
VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM...
K130860 · LCP
Bio-Rad Laboratories, Inc., Clinical...
Chemistry · 28d
Cleared Oct 26, 2012
VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
K122472 · LCP
Bio-Rad Laboratories, Inc., Clinical...
Chemistry · 73d
Cleared Mar 27, 2012
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE...
K120504 · DIF
Bio-Rad Laboratories, Inc.
Chemistry · 35d
Cleared Mar 26, 2012
BIOPLEX 2200 TORC IGG
K120572 · OMI
Bio-Rad Laboratories, Inc.
Microbiology · 28d
Cleared Mar 14, 2012
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
K120439 · LIP
Bio-Rad Laboratories, Inc.
Microbiology · 30d
Cleared Oct 29, 2009
MONOLISA ANTI-HAV EIA
K092355 · LOL
Bio-Rad Laboratories, Inc.
Microbiology · 86d
Cleared Oct 29, 2009
MONOLISA ANTI-HAV IGM EIA
K092353 · LOL
Bio-Rad Laboratories, Inc.
Microbiology · 86d
Cleared Jul 27, 2009
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS...
K090699 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 132d
Cleared Jun 03, 2009
HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY...
K090737 · JKA
Bio-Rad Laboratories, Inc.
Chemistry · 75d
Cleared Feb 23, 2009
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
K080008 · OMI
Bio-Rad Laboratories, Inc.
Microbiology · 418d
Cleared May 07, 2007
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
K070452 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 80d
Cleared Dec 08, 2006
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K062213 · LSE
Bio-Rad Laboratories, Inc.
Microbiology · 129d
Cleared Dec 08, 2006
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K062211 · LSE
Bio-Rad Laboratories, Inc.
Microbiology · 129d
Cleared Dec 01, 2006
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
K063400 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 22d
Cleared Jan 20, 2006
D-10 HEMOGLOBIN A1C PROGRAM
K060001 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 17d