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510(k) K021793

EBV EA-D IGG ELISA KIT, MODEL EBG-100 by Pan Bio Pty. , Ltd. — Product Code LSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2002
Date Received
May 31, 2002
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

Other clearances by Pan Bio Pty. , Ltd.

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  • K020707 — EBV-EBNA IGG ELISA KIT, MODEL EBG-100 (June 13, 2002)
  • K020706 — EBV-VCA IGG ELISA TEST, MODEL EBG-100 (June 13, 2002)

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