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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 K161837
Device Name ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
Applicant
Beckman Coulter, Inc.
250 S. Kraemer Blvd. Mails Stop E1.Se.01
Brea,  CA  92821
Applicant Contact GERALDINE FUENTESPINA
Correspondent
Beckman Coulter, Inc.
250 S. Kraemer Blvd. Mails Stop E1.Se.01
Brea,  CA  92821
Correspondent Contact GERALDINE FUENTESPINA
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CFR   CGZ   JJE   NQD  
Date Received07/05/2016
Decision Date 12/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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