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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 K020364
Device Name PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
Applicant
Phoenix Diagnostics, Inc.
8 Tech Circle
Natick,  MA  01760
Applicant Contact RAN NUNNA
Correspondent
Phoenix Diagnostics, Inc.
8 Tech Circle
Natick,  MA  01760
Correspondent Contact RAN NUNNA
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ   CHL   JIX  
Date Received02/04/2002
Decision Date 06/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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