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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Cf, Epstein-Barr Virus
510(k) Number K020707
Device Name EBV-EBNA IGG ELISA KIT, MODEL EBG-100
Applicant
Pan Bio Pty. , Ltd.
116 Lutwyche Rd.
Windsor,  AU 4030
Applicant Contact HELEN JENNINGS
Correspondent
Pan Bio Pty. , Ltd.
116 Lutwyche Rd.
Windsor,  AU 4030
Correspondent Contact HELEN JENNINGS
Regulation Number866.3235
Classification Product Code
GNP  
Date Received03/04/2002
Decision Date 06/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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