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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name herpes simplex virus nucleic acid amplification assay
510(k) Number K172509
Device Name Sentosa SA201 HSV 1/2 Qualitative PCR Test
Applicant
Vela Diagnostics USA Inc.
353C US Route 46 West
Suite 250
Fairfield,  NJ  07004
Applicant Contact Donald Henton
Correspondent
Vela Diagnostics USA Inc.
353C US Route 46 West
Suite 250
Fairfield,  NJ  07004
Correspondent Contact Donald Henton
Regulation Number866.3305
Classification Product Code
OQO  
Date Received08/21/2017
Decision Date 02/01/2018
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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