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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name rickettsia spp. nucleic acid based detection assay
510(k) Number K170940
Device Name Rickettsia Real-time PCR Assay
Applicant
Centers for Disease Control and Prevention (CDC)
1600 Clifton Road
MS-C18
atlanta,  GA  30329
Applicant Contact yon yu
Correspondent
Centers for Disease Control and Prevention (CDC)
1600 Clifton Road
MS-C18
atlanta,  GA  30329
Correspondent Contact yon yu
Regulation Number866.3316
Classification Product Code
PVQ  
Date Received03/30/2017
Decision Date 06/29/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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