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510(k) K873345

'MICROLYTE 4/5' by Kone Instruments, Inc. — Product Code JFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1987
Date Received
August 19, 1987
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 Kone Instruments, Inc.

  • K870777 — PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER (March 13, 1987)
  • K863466 — M700 STRESS MONITOR (December 22, 1986)
  • K862655 — SIGNA II RESTING ECG ELECTRODE (August 6, 1986)
  • K860767 — MODEL E 600 ELECTROCARDIOGRAPH (April 23, 1986)
  • K853354 — MEDIC 4 (October 11, 1985)
  • K840200 — PROGRESS SELECTIVE DHEMISTRY ANALYZ (April 4, 1984)
  • K830432 — CENTRAL STATION 590 (March 24, 1983)
  • K830433 — PATIENT MONITOR 575 (March 24, 1983)
  • K822952 — 560 (November 1, 1982)
  • K820541 — MICROLYTE (May 24, 1982)

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