FDA 510(k) Applications Submitted by Yon Yu
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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 |
| 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) |
| K181205 |
05/07/2018 |
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set |
Centers for Disease Control and Prevention |
| 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) |
| 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 |
| 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) |
| K141859 |
07/10/2014 |
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
| K192847 |
10/03/2019 |
AUTOLIGN |
Diorco Co., Ltd. |
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