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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 K031952
Device Name WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M
Applicant
Focus Technologies, Inc.
10703 Progress Way
Cypress,  CA  90630
Applicant Contact MICHAEL J WAGNER
Correspondent
Focus Technologies, Inc.
10703 Progress Way
Cypress,  CA  90630
Correspondent Contact MICHAEL J WAGNER
Regulation Number866.3940
Classification Product Code
NOP  
Date Received06/25/2003
Decision Date 10/22/2003
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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