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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Albumin, Antigen, Antiserum, Control
510(k) Number K082251
Device Name SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd.
Ms 110
Brea,  CA  92821
Applicant Contact MARINE BOYAJIAN
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd.
Ms 110
Brea,  CA  92821
Correspondent Contact MARINE BOYAJIAN
Regulation Number866.5040
Classification Product Code
DCF  
Date Received08/08/2008
Decision Date 04/08/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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
Recalls CDRH Recalls
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