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FDA 510(k) Applications Submitted by HYE-JOO KIM, PHARM.D.
FDA 510(k) Number
Submission Date
Device Name
Applicant
DEN070001
01/16/2007
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME 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
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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