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510(k) K030863

EBV VCA-P18 IGG ELISA by Panbio Limited — Product Code LSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2003
Date Received
March 18, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Epstein-Barr Virus, Other
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

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  • DEN030004 — WEST NILE VIRUS IGM CAPTURE ELISA (July 8, 2003)

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