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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
510(k) Number K222558
Device Name Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Applicant
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS-H24-11
Atlanta,  GA  30329
Applicant Contact Julie Villanueva, PhD
Correspondent
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS-H24-11
Atlanta,  GA  30329
Correspondent Contact Julie Villanueva, PhD
Classification Product Code
PBK  
Date Received08/24/2022
Decision Date 08/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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