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510(k) K033106

CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT by Trinity Biotech USA — Product Code MYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2004
Date Received
September 30, 2003
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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