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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunochemical, Bence-Jones Protein
510(k) Number K050119
Device Name PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd.
P.O. Box 8000, M/S W-515
Brea,  CA  92822
Applicant Contact KIM WALKER
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd.
P.O. Box 8000, M/S W-515
Brea,  CA  92822
Correspondent Contact KIM WALKER
Regulation Number866.5150
Classification Product Code
JKM  
Subsequent Product Codes
CFF   DEH   DFH  
Date Received01/18/2005
Decision Date 05/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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