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510(k) K131334

HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST by Gold Standard Diagnostics — Product Code MXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2014
Date Received
May 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

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