510(k) clearance
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit)
- 510(k) number
- K263035
- Applicant
- Centers for Disease Control and Prevention
- Decision date
- Sep 30, 2026
- Date received
- Aug 31, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- OZE
- Device type
- Influenza A And Influenza B Multiplex Nucleic Acid Assay
- Device class
- Class II
- Regulation
- 21 CFR 866.3980
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Atlanta, GA, US