510(k) Report

Devices descending from K101564

19 later devices reach CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR Panel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111778Jbaids Influenza a Subtyping KitU.S Army Medical Materiel Development Activity20110—
+1K111507CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention201117—
+2K130551CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention201315—
+2K123905CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention20130—
+3K132508CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention201314—
+4K141859CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza a/H5 SubtypingCenters for Disease Control and Prevention20149—
+4K140851Influenza a Subtyping Kit, CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention20149—
+4K140857Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-Time RT-PCR…Centers for Disease Control and Prevention20148—
+4K133869CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza a/B Typing KitCenter For Disease Control and Prevention (Cdc)20148—
+5K172091CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…Centers for Disease Control and Prevention20177—
+5K161556CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping KitCenters For Disease Control and Prevention (CDC)20168—
+5K153148CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 SubtypingCenters For Disease Control and Prevention (CDC)20158—
+6K190302CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…Centers for Disease Control and Prevention20195—
+6K181736CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage…Centers For Disease Control and Prevention (CDC)20186—
+7K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…Centers for Disease Control and Prevention20252—
+7K200370CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…Centers for Disease Control and Prevention202011
+8K243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…Centers for Disease Control and Prevention20251—
+8K241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit…Centers for Disease Control and Prevention20240—
+9K263035CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B…Centers for Disease Control and Prevention20260—