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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K103842
Device Name UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
Applicant
BECKMAN COULTER, INC.
250 S. KRAEMER BOULEVARD
MAIL STOP E2 SE08
BREA,  CA  92821
Applicant Contact MARINE BOYAJIAN
Correspondent
BECKMAN COULTER, INC.
250 S. KRAEMER BOULEVARD
MAIL STOP E2 SE08
BREA,  CA  92821
Correspondent Contact MARINE BOYAJIAN
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
JJE  
Date Received12/30/2010
Decision Date 04/27/2011
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
Recalls CDRH Recalls
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