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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 K874185
Device Name DART (R) ELECTROLYTE REAGENT SYSTEM
Applicant
Coulter Electronics, Inc.
745 W. 83rd St.
Hialeah,  FL  33014
Applicant Contact RICHARDSON-JONES
Correspondent
Coulter Electronics, Inc.
745 W. 83rd St.
Hialeah,  FL  33014
Correspondent Contact RICHARDSON-JONES
Regulation Number862.1665
Classification Product Code
JGS  
Date Received10/14/1987
Decision Date 11/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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