Francisella tularensis Real-time PCR Assay— 510(k) K260812

Name: FDA 510(k) clearance K260812
Creator: U.S. Food and Drug Administration
Published: 2026-03-30

Substantially Equivalent

Centers 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.

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: 2026-03-13
Decision date: 2026-03-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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