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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 K023049
Device Name SYNCHRON LX I 725 CLINICAL SYSTEM
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Applicant Contact MARY BETH TANG
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Correspondent Contact MARY BETH TANG
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CDD   CDP   CDQ   CDZ   CEC  
CEE   CEK   CEM   CEO   CFJ   CFR  
CGA   CGR   CGS   CGX   CGZ   CHH  
CIN   CJE   CJW   CZP   DCF   DCK  
DDC   DDG   DDR   DEW   DFT   DGC  
DHR   DHX   DIH   DIO   DIS   DJG  
DJR   DKJ   DKZ   DLZ   DMT   GTQ  
JFJ   JFL   JFM   JFP   JHI   JHW  
JHX   JIF   JIY   JJE   JLW   JMG  
JMO   JXM   KLI   KLS   KLT   KXS  
KXT   LCD   LCM   LCP   LCR   LDJ  
LDP   LEG   LFX   LGD   LJC   MRR  
MSJ   MSW  
Date Received09/12/2002
Decision Date 10/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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