510(k) K200370 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 A/H5 Subtyping Kit
| Applicant | Centers for Disease Control and Prevention, Atlanta GA, US |
| Decision | Substantially Equivalent, Mar 10, 2020 |
| Received | Feb 14, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200370
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2024 | Centers For Disease Control and Prevention CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11 Terminated |
OZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.