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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
510(k) Number K163133
Device Name ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA
Applicant
Immco Diagnostics, Inc.
9870 Hollingson Rd.
Clarence,  NY  14031
Applicant Contact Kevin Lawson
Correspondent
Immco Diagnostics, Inc.
9870 Hollingson Rd.
Clarence,  NY  14031
Correspondent Contact Kevin Lawson
Regulation Number866.5090
Classification Product Code
DBM  
Date Received11/08/2016
Decision Date 08/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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