CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL— 510(k) K101564
Substantially EquivalentCenters for Disease Control and Prevention
FDA 510(k) clearance K101564 for CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL, Substantially Equivalent on 2010-06-22. 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
- Traditional
- Location
- Atlanta, GA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.