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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 K152353
Device Name SeraQuest HSV Type 2 Specific IgG
Applicant
Quest International, Inc.
8127 NW 29th St.
Mami,  FL  33122
Applicant Contact David J Kiefer
Correspondent
Quest International, Inc.
8127 NW 29th St.
Mami,  FL  33122
Correspondent Contact David J Kiefer
Regulation Number866.3305
Classification Product Code
MYF  
Date Received08/20/2015
Decision Date 05/13/2016
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
Predetermined Change
Control Plan Authorized		 No
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