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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 Road NE, MS-C18
atlanta,  GA  30329
Applicant Contact yon yu
Correspondent
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS-C18
atlanta,  GA  30329
Correspondent Contact yon yu
Regulation Number866.3315
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
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