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Centers for Disease Control and Prevention

FDA 510(k) & PMA Approved Devices — 25 products

Total Devices25
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K262368 B. anthracis Real-time PCR AssayNHT2026-10-07 View
510(k) K263035 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)OZE2026-09-30 View
510(k) K260812 Francisella tularensis Real-time PCR AssaySGA2026-03-30 View
510(k) K252072 Francisella tularensis Real-time PCR assaySGA2025-09-30 View
510(k) K243274 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)OZE2025-07-11 View
510(k) K243931 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)OZE2025-03-14 View
510(k) K241110 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)OZE2024-05-21 View
510(k) K222558 Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK2022-08-30 View
510(k) K221834 Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK2022-06-24 View
510(k) K221658 Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK2022-06-10 View
510(k) K200370 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 KitOZE2020-03-10 View
510(k) K192871 B. anthracis Real-time PCR AssayNHT2019-11-07 View
510(k) K190302 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, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping KitOZE2019-03-27 View
510(k) K181205 Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK2018-09-20 View
510(k) K172091 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, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping KitOZE2017-08-09 View
510(k) K132508 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELOZE2013-09-23 View
510(k) K130551 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELOQW2013-05-22 View
510(k) K123905 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELOQW2013-01-14 View
510(k) K111507 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELOQW2011-08-23 View
510(k) K101564 CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANELOQW2010-06-22 View
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