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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 K853531
Device Name ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER
Applicant
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Applicant Contact JAMES E KELLER
Correspondent
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Correspondent Contact JAMES E KELLER
Regulation Number862.1600
Classification Product Code
CEM  
Date Received08/23/1985
Decision Date 09/04/1985
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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