510(k) K243274 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 (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
| Applicant | Centers for Disease Control and Prevention, Atlanta GA, US |
| Decision | Substantially Equivalent, Jul 11, 2025 |
| Received | Oct 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243274
No recall in the FDA data names this 510(k).
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