CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL— 510(k) K123905
Substantially EquivalentCenters for Disease Control and Prevention
FDA 510(k) clearance K123905 for CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, Substantially Equivalent on 2013-01-14. Applicant: Centers for Disease Control and Prevention. Device class: 2.
Clearance details
- Applicant
- Centers for Disease Control and Prevention
- Product code
- Code OQW
- Device class
- Class 2
- Regulation
- 21 CFR 866.3332
- 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.