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510(k) K260812

Francisella tularensis Real-time PCR Assay by Centers for Disease Control and Prevention — Product Code SGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2026
Date Received
March 13, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biothreat Microbial Agent Nucleic Acid Detection Test
Device Class
Class II
Regulation Number
866.4000
Review Panel
MI
Submission Type

A biothreat microbial agent nucleic acid detection test is a qualitative in vitro diagnostic device for the detection and identification of biothreat microbial agent–associated nucleic acids in human clinical specimens.

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Other clearances for product code SGA

  • K252072 — Francisella tularensis Real-time PCR assay (September 30, 2025)