FDA 510(k) Applications Submitted by Centers for Disease Control and Prevention (CDC)

FDA 510(k) Number Submission Date Device Name Applicant
K140426 02/19/2014 ANTHRACIS REAL-TIME PCR ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
K170940 03/30/2017 Rickettsia Real-time PCR Assay Centers for Disease Control and Prevention (CDC)
DEN160016 04/14/2016 Variola virus Real-Time PCR Assay CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
K161556 06/06/2016 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit Centers for Disease Control and Prevention (CDC)
K181736 07/02/2018 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, Centers for Disease Control and Prevention (CDC)
K153148 10/30/2015 CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)


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