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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 K181205
Device Name Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Applicant
Centers For Disease Control and Prevention
1600 Clifton Rd. NE, Ms-C18
Atlanta,  GA  30329
Applicant Contact Yon Yu
Correspondent
Centers For Disease Control and Prevention
1600 Clifton Rd. NE, Ms-C18
Atlanta,  GA  30329
Correspondent Contact Yon Yu
Classification Product Code
PBK  
Date Received05/07/2018
Decision Date 09/20/2018
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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