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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, Potassium
510(k) Number K843239
Device Name DACOS PLUS LYTES OPTION
Applicant
Coulter Electronics, Inc.
590 W. 20th St.
Hialeah,  FL  33010
Applicant Contact RICHARDSON-JONES
Correspondent
Coulter Electronics, Inc.
590 W. 20th St.
Hialeah,  FL  33010
Correspondent Contact RICHARDSON-JONES
Regulation Number862.1600
Classification Product Code
CEM  
Date Received08/22/1984
Decision Date 10/17/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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