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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 K041231
Device Name WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
Applicant
PANBIO LIMITED
116 LUTWYCHE RD.
WINDSOR, BRISBANE,  AU 4030
Applicant Contact CRAIG BREADMORE
Correspondent
PANBIO LIMITED
116 LUTWYCHE RD.
WINDSOR, BRISBANE,  AU 4030
Correspondent Contact CRAIG BREADMORE
Regulation Number866.3940
Classification Product Code
NOP  
Date Received05/10/2004
Decision Date 08/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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