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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 K181329
Device Name EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
Applicant
Phadia AB
Rapsgatan 7p
Uppsala,  SE SE 754 50
Applicant Contact Carina Magnusson
Correspondent
Phadia US, Inc.
4169 Commercial Ave.
Portae,  MI  49002
Correspondent Contact Martin Robert Mann
Regulation Number866.5660
Classification Product Code
MSV  
Subsequent Product Code
MID  
Date Received05/18/2018
Decision Date 06/25/2018
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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