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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Nucleic Acid Amplification, Bacillus Anthracis
510(k) Number K262368
Device Name B. anthracis 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
Regulation Number866.3045
Classification Product Code
NHT  
Date Received07/10/2026
Decision Date 10/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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