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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Autoantibodies, Endomysial(Tissue Transglutaminase)
510(k) Number K123713
Device Name IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA
Applicant
Immco Diagnostics, Inc.
60 Pineview Dr.
Buffalo,  NY  14228
Applicant Contact KEVIN J LAWSON
Correspondent
Immco Diagnostics, Inc.
60 Pineview Dr.
Buffalo,  NY  14228
Correspondent Contact KEVIN J LAWSON
Regulation Number866.5660
Classification Product Code
MVM  
Subsequent Product Code
MST  
Date Received12/04/2012
Decision Date 10/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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