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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 K221658
Device Name Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Applicant
Centers For Disease Control and Prevention
1600 Clifton Rd. NE
Ms: H24-11
Atlanta,  GA  30329
Applicant Contact Julie Villanueva, PhD
Correspondent
Centers For Disease Control and Prevention
1600 Clifton Rd. NE
Ms: H24-11
Atlanta,  GA  30329
Correspondent Contact Julie Villanueva, PhD
Classification Product Code
PBK  
Date Received06/08/2022
Decision Date 06/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
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		 No
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