SYNCHRON LX I 725 CLINICAL SYSTEM


Device Classification Name

electrode, ion specific, sodium

510(k) Number K023049
Device Name SYNCHRON LX I 725 CLINICAL SYSTEM
Original Applicant
BECKMAN COULTER, INC.
200 south kraemer blvd. w-110
brea, 
CA 
92822

Original Contact mary beth tang
Regulation Number 862.1665
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 Received 09/12/2002
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

Recalls CDRH Recalls