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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 K860354
Device Name SEPRACELL LYMPHOCYTE SEPARATION MEDIUM
Applicant
Sepratech Corporation C/O Keller and Heckman
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Applicant Contact LA CRUZ
Correspondent
Sepratech Corporation C/O Keller and Heckman
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Correspondent Contact LA CRUZ
Regulation Number864.8500
Classification Product Code
JCF  
Date Received01/30/1986
Decision Date 04/18/1986
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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