510(k) Report

Devices descending from K141859

9 later devices reach CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza a/H5… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153148CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 SubtypingCenters For Disease Control and Prevention (CDC)20158—
+2K172091CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…Centers for Disease Control and Prevention20177—
+3K190302CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…Centers for Disease Control and Prevention20195—
+3K181736CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage…Centers For Disease Control and Prevention (CDC)20186—
+4K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…Centers for Disease Control and Prevention20252—
+4K200370CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…Centers for Disease Control and Prevention202011
+5K243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…Centers for Disease Control and Prevention20251—
+5K241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit…Centers for Disease Control and Prevention20240—
+6K263035CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B…Centers for Disease Control and Prevention20260—