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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lymphocyte Separation Medium
510(k) Number K902445
Device Name LYMPHO SEP(TM)
Applicant
Icn Biomedicals, Inc.
3300 Hyland Ave.
Costa Mesa,  CA  92626
Applicant Contact L. S SUDBURY
Correspondent
Icn Biomedicals, Inc.
3300 Hyland Ave.
Costa Mesa,  CA  92626
Correspondent Contact L. S SUDBURY
Regulation Number864.8500
Classification Product Code
JCF  
Date Received06/01/1990
Decision Date 08/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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