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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 K181334
Device Name ADVIA Centaur Herpes-2 IgG
Applicant
Biokit, S.A.
Can Male S/N
Lliça D'Amunt,  ES 08186
Applicant Contact Joan Guixe
Correspondent
Biokit, S.A.
Can Male S/N
Lliça D'Amunt,  ES 08186
Correspondent Contact Joan Guixe
Regulation Number866.3305
Classification Product Code
MYF  
Subsequent Product Code
LGC  
Date Received05/21/2018
Decision Date 08/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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