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510(k) K103603

ZEUS ELISA HSV GG-2 IGG TEST SYSTEM by Zeus Scientific, Inc. — Product Code MYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2011
Date Received
December 8, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

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