ClearanceBrief
510(k) K153148 ยท OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay

CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping

ApplicantCenters For Disease Control and Prevention (CDC), Atlanta GA, US
DecisionSubstantially Equivalent, Dec 1, 2015
ReceivedOct 30, 2015
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K153148

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.