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— 510(k) K200370
Substantially EquivalentCenters for Disease Control and Prevention
FDA 510(k) clearance K200370 for 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, Substantially Equivalent on 2020-03-10. Applicant: Centers for Disease Control and Prevention.
Clearance details
- Applicant
- Centers for Disease Control and Prevention
- Product code
- Code OZE
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Atlanta, GA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.