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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bordetella pertussis dna assay system
510(k) Number K183223
Device Name Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
Applicant
DiaSorin Molecular LLC
11331 Valley View Street
cypress,  CA  90630
Applicant Contact sharon young
Correspondent
DiaSorin Molecular LLC
11331 Valley View Street
cypress,  CA  90630
Correspondent Contact sharon young
Regulation Number866.3980
Classification Product Code
OZZ  
Subsequent Product Code
OOI  
Date Received11/20/2018
Decision Date 12/19/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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