510(k) Report

Devices descending from K190302

5 later devices reach CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…Centers for Disease Control and Prevention20252—
+1K200370CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…Centers for Disease Control and Prevention202011
+2K243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…Centers for Disease Control and Prevention20251—
+2K241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit…Centers for Disease Control and Prevention20240—
+3K263035CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B…Centers for Disease Control and Prevention20260—