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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biothreat Microbial Agent Nucleic Acid Detection Test
510(k) Number K252072
Device Name Francisella tularensis Real-time PCR assay
Applicant
Centers for Disease Control and Prevention
1600 Clifton Rd., NE
Ms H24-2
Atlanta,  GA  30329
Applicant Contact Jasmine Chaitram
Correspondent
Centers for Disease Control and Prevention
1600 Clifton Rd., NE
Ms H24-2
Atlanta,  GA  30329
Correspondent Contact Andita Clarke
Classification Product Code
SGA  
Date Received07/01/2025
Decision Date 09/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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