FDA 510(k) Applications Submitted by HYE-JOO KIM, PHARM.D

FDA 510(k) Number Submission Date Device Name Applicant
K060159 01/20/2006 INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET CENTERS FOR DISEASE CONTROL AND PREVENTION
DEN060008 01/27/2006 INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET CENTERS FOR DISEASE CONTROL AND PREVENTION
K140426 02/19/2014 ANTHRACIS REAL-TIME PCR ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
DEN120012 03/12/2012 CDC DENV-1-4 REAL TIME RT-PCT ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTION
K101564 06/04/2010 CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION
K113336 11/14/2011 CDC DENV-1-4 REAL TIME RT-PCT ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTION
K133869 12/20/2013 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT CENTER FOR DISEASE CONTROL AND PREVENTION (CDC)
K123905 12/19/2012 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION
K130551 03/04/2013 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION
K132508 08/12/2013 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION


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