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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 K091556
Device Name HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS
Applicant
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730
Applicant Contact CAROL MARBLE
Correspondent
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730
Correspondent Contact CAROL MARBLE
Regulation Number866.5660
Classification Product Code
MSV  
Subsequent Product Code
JJX  
Date Received05/27/2009
Decision Date 05/21/2010
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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