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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, ion specific, potassium
510(k) Number K112412
Device Name AU5800(R) CHEMISTRY ANALYZER
Applicant
BECKMAN COULTER, INC.
250 S. KRAEMER BOULEVARD
MAIL STOP E2 SE08
BREA,  CA  92821
Applicant Contact DAVID G DAVIS
Correspondent
BECKMAN COULTER, INC.
250 S. KRAEMER BOULEVARD
MAIL STOP E2 SE08
BREA,  CA  92821
Correspondent Contact DAVID G DAVIS
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CFR   JGJ   JJE  
Date Received08/22/2011
Decision Date 12/23/2011
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
Recalls CDRH Recalls
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