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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-1
510(k) Number K181333
Device Name ADVIA Centaur Herpes-1 IgG
Applicant
Biokit, S.A.
Can Male S/N
Lliça D'Amunt,  ES 08186
Applicant Contact Joan Guixer
Correspondent
Biokit, S.A.
Can Male S/N
Lliça D'Amunt,  ES 08186
Correspondent Contact Joan Guixer
Regulation Number866.3305
Classification Product Code
MXJ  
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
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