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510(k) K840200

PROGRESS SELECTIVE DHEMISTRY ANALYZ by Kone Instruments, Inc. — Product Code JJF

K840200 is an FDA 510(k) premarket notification submitted by Kone Instruments, Inc. for the device "PROGRESS SELECTIVE DHEMISTRY ANALYZ". The FDA issued a decision of Substantially Equivalent on April 4, 1984. The device falls under product code JJF (Analyzer, Chemistry, Micro, For Clinical Use), a Class I device regulated under 21 CFR 862.2170. Kone Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1984
Date Received
January 19, 1984
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)
  • K830432 — CENTRAL STATION 590 (March 24, 1983)
  • K830433 — PATIENT MONITOR 575 (March 24, 1983)
  • K822952 — 560 (November 1, 1982)
  • K820541 — MICROLYTE (May 24, 1982)

Other clearances for product code JJF

  • K052794 — ETI-MAX 3000 (March 31, 2006)
  • K040332 — POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER (June 16, 2004)
  • K033734 — LIGHTCYCLER INSTRUMENT VERSION 1.2 (December 17, 2003)
  • K013654 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER (June 5, 2002)
  • K012966 — ROCHE COBAS TAQMAN ANALYZER (February 1, 2002)
  • K993634 — CARESIDE ANALYZER (December 2, 1999)
  • K973628 — VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA (March 13, 1998)
  • K980056 — CARESIDE ANALYZER (March 6, 1998)
  • K973177 — MAGO AUTOMATED EIA PROCESSOR (October 9, 1997)
  • K971491 — SYNERMED IR 200 CHEMISTRY ANALYZER (June 26, 1997)

FDA data resources