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FDA 510(k) Application Details - K181334
Device Classification Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
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510(K) Number
K181334
Device Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Applicant
Biokit, S.A.
Can Male, S/N
Llica d'Amunt 08186 ES
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Contact
Joan Guixe
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Regulation Number
866.3305
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Classification Product Code
MYF
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Date Received
05/21/2018
Decision Date
08/23/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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