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510(k) K851808

ELECTROLYTE ANALYZER by Ionetics, Inc. — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1985
Date Received
April 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

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  • K863907 — MODIFIED SODIUM ELECTRODE (December 10, 1986)
  • K830130 — MINIATURE ION SELECTIVE ELECTRODES (March 7, 1983)
  • K802856 — MINIATURE ION SELECTIVE ELECTRODES (January 28, 1981)

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