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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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