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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 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
Regulation Number866.3315
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
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