Francisella tularensis Real-time PCR assay— 510(k) K252072
Substantially EquivalentCenters for Disease Control and Prevention
FDA 510(k) clearance K252072 for Francisella tularensis Real-time PCR assay, Substantially Equivalent on 2025-09-30. Applicant: Centers for Disease Control and Prevention. Device class: 2.
Clearance details
- Applicant
- Centers for Disease Control and Prevention
- Product code
- Code SGA
- Device class
- Class 2
- Regulation
- 21 CFR 866.4000
- Advisory panel
- Immunology
- 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.