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510(k) K061239

EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT by Euroimmun Us, LLC — Product Code MYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2007
Date Received
May 3, 2006
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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