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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 K042291
Device Name UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD.,W-104
P.O. BOX 8000
BREA,  CA  92822 -8000
Applicant Contact MARY BETH TANG
Correspondent
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD.,W-104
P.O. BOX 8000
BREA,  CA  92822 -8000
Correspondent Contact MARY BETH TANG
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CEK   CEO   CFJ   CGA   CGX  
CJW   DCK   DLZ   JFL   JFP   JGJ  
JGS   JIY   JJE   JXM   LFP  
Date Received08/24/2004
Decision Date 11/12/2004
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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