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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody, Antigen, Control
510(k) Number K842484
Device Name LEAP LE TEST KIT
Applicant
Cooper Biomedical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Cooper Biomedical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received06/25/1984
Decision Date 07/11/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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