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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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