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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 K030702
Device Name IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM 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
MSV  
Date Received03/06/2003
Decision Date 09/09/2003
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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