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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoelectrophoretic, Immunoglobulins, (G, A, M)
510(k) Number K111369
Device Name THE HELENA V8 IMMUNODISPLACEMENT KIT
Applicant
Helena Laboratories Uk, Ltd.
P.O. Box 752, 1530 Lindebergh
Drive
Beaumont,  TX  77704 -0752
Applicant Contact PATRICIA FRANKS
Correspondent
Helena Laboratories Uk, Ltd.
P.O. Box 752, 1530 Lindebergh
Drive
Beaumont,  TX  77704 -0752
Correspondent Contact PATRICIA FRANKS
Regulation Number866.5510
Classification Product Code
CFF  
Date Received05/16/2011
Decision Date 06/26/2012
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
Recalls CDRH Recalls
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