Francisella tularensis Real-time PCR assay— 510(k) K252072

Name: FDA 510(k) clearance K252072
Creator: U.S. Food and Drug Administration
Published: 2025-09-30

Substantially Equivalent

Centers 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: Product code SGA
Device class: Class 2
Regulation: 21 CFR 866.4000
Advisory panel: Immunology
Date received: 2025-07-01
Decision date: 2025-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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