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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 K033915
Device Name MODIFICATION TO SERAQUEST EB VCA IGG
Applicant
Quest Intl., Inc.
1938 NE 148th Terr.
North Miami,  FL  33181
Applicant Contact ROBERT A CORT
Correspondent
Quest Intl., Inc.
1938 NE 148th Terr.
North Miami,  FL  33181
Correspondent Contact ROBERT A CORT
Regulation Number866.3235
Classification Product Code
LSE  
Date Received12/18/2003
Decision Date 01/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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