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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
510(k) Number K912551
Device Name ANTI-ENDOMYSIAL ANTIBODY TEST
Applicant
Immco Diagnostics, Inc.
963 Kenmore Ave.
Buffalo,  NY  14223
Applicant Contact SUSAN KRASNY
Correspondent
Immco Diagnostics, Inc.
963 Kenmore Ave.
Buffalo,  NY  14223
Correspondent Contact SUSAN KRASNY
Regulation Number866.5660
Classification Product Code
DBL  
Date Received06/11/1991
Decision Date 06/09/1993
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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