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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
510(k) Number K810983
Device Name ANTISMOOTH MUSCLE ANTIBODY TEST SYS
Applicant
Immuno-Products Industries
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Immuno-Products Industries
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5120
Classification Product Code
DBE  
Date Received04/13/1981
Decision Date 05/01/1981
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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