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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 K031177
Device Name DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
Applicant
Axis-Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1XA
Applicant Contact EILEEN MCCAFFERTY
Correspondent
Axis-Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1XA
Correspondent Contact EILEEN MCCAFFERTY
Regulation Number866.5660
Classification Product Code
MSV  
Date Received04/14/2003
Decision Date 06/19/2003
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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