Francisella tularensis Real-time PCR Assay— 510(k) K260812
Substantially EquivalentCenters for Disease Control and Prevention
FDA 510(k) clearance K260812 for Francisella tularensis Real-time PCR Assay, Substantially Equivalent on 2026-03-30. Applicant: Centers for Disease Control and Prevention. Device class: 2.
Summary
The Centers for Disease Control and Prevention is the applicant for the Francisella tularensis Real-time PCR Assay, filed under SGA, biothreat microbial agent nucleic acid detection tests. The record doesn't describe the assay beyond its name and that code name.
Class II, 21 CFR 866.4000. The Microbiology review panel handled it as a Special 510(k), though the record lists Immunology as the classification panel.
The applicant filed from Atlanta, Georgia. Review took 17 calendar days (March 13 to March 30, 2026).
Clearance details
- Applicant
- Centers for Disease Control and Prevention
- Product code
- Product code SGA
- Device class
- Class 2
- Regulation
- 21 CFR 866.4000
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Atlanta, GA, US
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