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510(k) K895397

CALCIUM AND PH ELECTROLYTE ANALYZER by Ionetics, Inc. — Product Code JFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1989
Date Received
September 1, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by Ionetics, Inc.

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  • K863907 — MODIFIED SODIUM ELECTRODE (December 10, 1986)
  • K851808 — ELECTROLYTE ANALYZER (June 25, 1985)
  • K830130 — MINIATURE ION SELECTIVE ELECTRODES (March 7, 1983)
  • K802856 — MINIATURE ION SELECTIVE ELECTRODES (January 28, 1981)

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