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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Proliferation, In Vitro, T Lymphocyte
510(k) Number K101911
Device Name IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY
Applicant
Cylex, Inc.
P.O.Box 103
Baldwin,  MD  21013
Applicant Contact Judi Smith
Correspondent
Cylex, Inc.
P.O.Box 103
Baldwin,  MD  21013
Correspondent Contact Judi Smith
Regulation Number864.5220
Classification Product Code
NID  
Date Received07/09/2010
Decision Date 10/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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