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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
510(k) Number K202755
Device Name Simplexa Congenital CMV Direct and Simplexa Congenital CMV 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
Classification Product Code
QDZ  
Subsequent Product Code
OOI  
Date Received09/21/2020
Decision Date 11/05/2022
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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