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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Vitamin B12
510(k) Number K110413
Device Name POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
Applicant
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea,  CA  92822
Applicant Contact MARINE BOYAJIAN
Correspondent
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea,  CA  92822
Correspondent Contact MARINE BOYAJIAN
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Codes
CGN   DBF   JJE   JLW  
Date Received02/14/2011
Decision Date 05/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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