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510(k) K820541

MICROLYTE by Kone Instruments, Inc. — Product Code JJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1982
Date Received
March 2, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Micro, For Clinical Use
Device Class
Class I
Regulation Number
862.2170
Review Panel
CH
Submission Type

Other clearances by Kone Instruments, Inc.

  • K873345 — 'MICROLYTE 4/5' (September 11, 1987)
  • 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)

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