CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping— 510(k) K153148
Substantially EquivalentCenters For Disease Control and Prevention (CDC)
FDA 510(k) clearance K153148 for CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping, Substantially Equivalent on 2015-12-01. Applicant: Centers For Disease Control and Prevention (CDC). Device class: 2.
Clearance details
- Applicant
- Centers For Disease Control and Prevention (CDC)
- Product code
- Code OZE
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Atlanta, GA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.