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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name igg (fab fragment specific), antigen, antiserum, control
510(k) Number K790711
Device Name ANTISERA TO HUMAN FRAGMENT
Applicant
KENT LABORATORIES, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Correspondent
KENT LABORATORIES, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Regulation Number866.5520
Classification Product Code
DFK  
Date Received04/12/1979
Decision Date 09/04/1979
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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