K241110
- 510(k) number
- K241110
- Device name
- CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
- Applicant
- Centers for Disease Control and Prevention GA · US
- Product code
- OZE — Influenza A And Influenza B Multiplex Nucleic Acid A
- Decision date
- 2024-05-21
- Date received
- 2024-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K241110.pdf
Official FDA record: K241110
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.