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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme linked immunosorbent assay, herpes simplex virus, hsv-2
510(k) Number K181514
Device Name SeraQuest HSV Type 2 Specific IgG
Applicant
Quest International, Inc.
1935 SW Martin Highway
Palm City,  FL  34990
Applicant Contact Steve Andrus
Correspondent
Quest International, Inc.
1935 SW Martin Highway
Palm City,  FL  34990
Correspondent Contact Steve Andrus
Regulation Number866.3305
Classification Product Code
MYF  
Date Received06/08/2018
Decision Date 06/13/2019
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
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