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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