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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 K030863
Device Name EBV VCA-P18 IGG ELISA
Applicant
Panbio Limited
116 Lutwyche Rd.
Windsor,  AU 4030
Applicant Contact HELEN JENNINGS
Correspondent
Panbio Limited
116 Lutwyche Rd.
Windsor,  AU 4030
Correspondent Contact HELEN JENNINGS
Regulation Number866.3235
Classification Product Code
LSE  
Date Received03/18/2003
Decision Date 06/27/2003
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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