FDA 510(k) Applications Submitted by Juang Wang

FDA 510(k) Number Submission Date Device Name Applicant
K130053 01/15/2013 BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI BIO-RAD LABORATORIES, INC.
K170413 02/10/2017 BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set Bio-Rad Laboratories
K120439 02/13/2012 BIOPLEX 2200 EBV IGG AND SYPHILIS IGG BIO-RAD LABORATORIES, INC.
K120572 02/27/2012 BIOPLEX 2200 TORC IGG BIO-RAD LABORATORIES, INC.
K130528 03/01/2013 BIOPLEX 2200 APLS IGM Bio-Rad Laboratories
K120959 03/30/2012 BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT Bio-Rad Laboratories
K111072 04/18/2011 BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL Bio-Rad Laboratories
K141114 04/30/2014 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 Bio-Rad Laboratories
K112810 09/27/2011 MULTI-ANALYTE DETECTION SYSTEMS Bio-Rad Laboratories
K123021 09/27/2012 BIOPLEX 2200 EBV IGM KIT Bio-Rad Laboratories
K113610 12/06/2011 ANA-SCREEN WITH MDSS Bio-Rad Laboratories
K093954 12/23/2009 BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM Bio-Rad Laboratories
K103834 12/30/2010 BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS Bio-Rad Laboratories


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