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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameBeckman Coulter Unicel DxC 600i Synchron Access Clinical System  
Document NumberK060256
Parent Document NumberK060256
Analyte NameGamma glutamyl transferase (GGT)
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date03/22/2006
Device Classification Name Hexokinase, Glucose
510(k) Number K060256
Device Name UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd.
Brea,  CA  92622
Applicant Contact MARY BETH TANG
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd.
Brea,  CA  92622
Correspondent Contact MARY BETH TANG
Regulation Number862.1345
Classification Product Code
CFR  
Subsequent Product Codes
CDQ   CEM   CGN   CGZ   CHL  
DCK   DFT   JFP   JGS   JHI   JIY  
JJE   JLW   JMG   JXM   LCD   LCP  
Date Received02/01/2006
Decision Date 02/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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