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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ph Rate Measurement, Carbon-Dioxide
510(k) Number K014034
Device Name MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Applicant Contact ANNETTE HELLIE
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Correspondent Contact ANNETTE HELLIE
Regulation Number862.1160
Classification Product Code
JFL  
Subsequent Product Codes
CEM   CGZ   JFP   JGS  
Date Received12/07/2001
Decision Date 12/18/2001
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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