Centers For Disease Control and Prevention - FDA 510(k) Cleared Devic...
Recent clearances: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit), Francisella tularensis Real-time PCR assay, CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2)
30
Total
26
Cleared
4
Denied
FDA 510(k) Regulatory Record - Centers For Disease Control and Prevention Microbiology ✕
29 devices
Cleared
Sep 30, 2026
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes...
Microbiology
30d
Cleared
Sep 30, 2025
Francisella tularensis Real-time PCR assay
Microbiology
91d
Cleared
Jul 11, 2025
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B...
Microbiology
268d
Cleared
Mar 14, 2025
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B...
Microbiology
84d
Cleared
May 21, 2024
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A...
Microbiology
29d
Cleared
Aug 30, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Microbiology
6d
Cleared
Jun 24, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Microbiology
1d
Cleared
Jun 10, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Microbiology
2d
Cleared
Mar 10, 2020
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B...
Microbiology
25d
Cleared
Nov 07, 2019
B. anthracis Real-time PCR Assay
Microbiology
30d
Cleared
Mar 27, 2019
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B...
Microbiology
43d
Not Cleared
Sep 21, 2018
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
Microbiology
4266d