ClearanceBrief
510(k) K190302 ยท OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay

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, I

ApplicantCenters for Disease Control and Prevention, Atlanta GA, US
DecisionSubstantially Equivalent, Mar 27, 2019
ReceivedFeb 12, 2019
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K190302

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.