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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Epstein-Barr Virus, Other
510(k) Number K021793
Device Name EBV EA-D IGG ELISA KIT, MODEL EBG-100
Applicant
Pan Bio Pty. , Ltd.
116 Lutwyche Rd.
Windsor
Brisbane, Queensland,  AU 4030
Applicant Contact HELEN JENNINGS
Correspondent
Pan Bio Pty. , Ltd.
116 Lutwyche Rd.
Windsor
Brisbane, Queensland,  AU 4030
Correspondent Contact HELEN JENNINGS
Regulation Number866.3235
Classification Product Code
LSE  
Date Received05/31/2002
Decision Date 09/27/2002
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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