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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 K090588
Device Name POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd.
Brea,  CA  92821
Applicant Contact MARY B TANG
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd.
Brea,  CA  92821
Correspondent Contact MARY B TANG
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Codes
CGN   DBF   JJE   JLW  
Date Received03/04/2009
Decision Date 05/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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