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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name herpes virus (vzv, hsv1, hsv2), dna detection assay for cutaneous and mucocutaneous lesion samples
510(k) Number K192376
Device Name Simplexa VZV Swab Direct, Simplexa VZV 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 Number866.3309
Classification Product Code
PGI  
Subsequent Product Code
PMN  
Date Received08/30/2019
Decision Date 11/26/2019
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
Recalls CDRH Recalls
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