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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name c. difficile toxin gene amplification assay
510(k) Number K163085
Device Name Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack
Applicant
Focus Diagnostics, Inc.: DBA DiaSorin Molecular LLC
11331 Valley View Street
cypress,  CA  90630
Applicant Contact irene m. guzman
Correspondent
Focus Diagnostics, Inc.: DBA DiaSorin Molecular LLC
11331 Valley View Street
cypress,  CA  90630
Correspondent Contact irene m. guzman
Regulation Number866.3130
Classification Product Code
OZN  
Date Received11/03/2016
Decision Date 02/14/2017
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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