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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Anticardiolipin Immunological
510(k) Number K113020
Device Name IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
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
MID  
Date Received10/11/2011
Decision Date 10/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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