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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name assay, nucleic acid amplification, bacillus anthracis
510(k) Number K192871
Device Name B. anthracis Real-time PCR Assay
Applicant
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS: H24-11
atlanta,  GA  30329
Applicant Contact yon yu
Correspondent
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS: H24-11
atlanta,  GA  30329
Correspondent Contact julie villanueva
Regulation Number866.3045
Classification Product Code
NHT  
Date Received10/08/2019
Decision Date 11/07/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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