FDA 510(k) Applications Submitted by CENTERS FOR DISEASE CONTROL AND PREVENTION

FDA 510(k) Number Submission Date Device Name Applicant
K111507 06/01/2011 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION
K140851 04/03/2014 INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION
K140857 04/03/2014 INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION
DEN130005 05/28/2013 QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS CENTERS FOR DISEASE CONTROL AND PREVENTION
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
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
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
K221658 06/08/2022 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set Centers for Disease Control and Prevention
K221834 06/23/2022 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set Centers For Disease Control And Prevention
K222558 08/24/2022 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set Centers for Disease Control and Prevention
K080570 02/29/2008 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION
K993633 10/27/1999 SYNTHETIC VDRL ANTIGEN CENTERS FOR DISEASE CONTROL AND PREVENTION
K190302 02/12/2019 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, Centers for Disease Control and Prevention
K200370 02/14/2020 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit Centers For Disease Control And Prevention
K181205 05/07/2018 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set Centers for Disease Control and Prevention
K172091 07/11/2017 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, Centers for Disease Control and Prevention
K192871 10/08/2019 B. anthracis Real-time PCR Assay Centers for Disease Control and Prevention
K141859 07/10/2014 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING CENTERS FOR DISEASE CONTROL AND PREVENTION


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