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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 K851808
Device Name ELECTROLYTE ANALYZER
Applicant
Ionetics, Inc.
3020 Enterprise
Costa Mesa,  CA  92626
Applicant Contact KATER
Correspondent
Ionetics, Inc.
3020 Enterprise
Costa Mesa,  CA  92626
Correspondent Contact KATER
Regulation Number862.1600
Classification Product Code
CEM  
Date Received04/15/1985
Decision Date 06/25/1985
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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