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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elisa, Antibody, West Nile Virus
510(k) Number K041068
Device Name WEST NILE VIRUS IGG INDIRECT ELISA
Applicant
Panbio Limited
116 Lutwyche Rd.
Windsor,  AU 4030
Applicant Contact CRAIG BREADMORE
Correspondent
Panbio Limited
116 Lutwyche Rd.
Windsor,  AU 4030
Correspondent Contact CRAIG BREADMORE
Regulation Number866.3940
Classification Product Code
NOP  
Date Received04/26/2004
Decision Date 10/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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