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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, Anticardiolipin Immunological
510(k) Number K091845
Device Name CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
Applicant
Phadia US, Inc.
4169 Commercial Ave.
Portae,  MI  49002
Applicant Contact MARTIN ROBERT MANN
Correspondent
Phadia US, Inc.
4169 Commercial Ave.
Portae,  MI  49002
Correspondent Contact MARTIN ROBERT MANN
Regulation Number866.5660
Classification Product Code
MID  
Subsequent Product Codes
JJY   MSV  
Date Received06/22/2009
Decision Date 06/07/2010
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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