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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,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
510(k) Number K162788
Device Name ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 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 Number866.5660
Classification Product Code
MSV  
Date Received10/03/2016
Decision Date 06/19/2017
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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