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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, sodium
510(k) Number K011213
Device Name MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA,  CA  92822
Applicant Contact ANNETTE HELLIE
Correspondent
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA,  CA  92822
Correspondent Contact ANNETTE HELLIE
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CDQ   CDT   CEK   CEM   CEO  
CFJ   CGA   CGS   CGX   CGZ   CHH  
CHI   CIG   CIT   CJE   CJW   CKA  
CZP   DCF   DDG   DEW   DFT   DHR  
DIH   DIO   DIP   DIS   DJG   DJR  
DKJ   DKZ   DLZ   DMT   GTQ   JFJ  
JFL   JFM   JFP   JGJ   JHW   JIF  
JIY   JJJ   JJO   JMO   JQB   JXM  
JXN   JZJ   KLB   KLI   KLS   KLT  
KXS   KXT   LCD   LCM   LCP   LDJ  
LDP   LEG   LRC   MSJ  
Date Received04/20/2001
Decision Date 05/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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