Home / 510(k) Clearances / K822823

510(k) K822823

HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT by Eko Scann AB — Product Code LKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1982
Date Received
September 21, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Urine Particle
Device Class
Class II
Regulation Number
864.5200
Review Panel
HE
Submission Type

Other clearances by Eko Scann AB

  • K822873 — DEVETHERM (March 24, 1983)

Other clearances for product code LKM

  • K252580 — iQ200 Series (September 10, 2025)
  • K232416 — AUTION EYE AI-4510 Urine Particle Analysis System (May 3, 2024)
  • K210127 — iQ200 System, iChemVELOCITY Automated Urine Chemistry System (July 2, 2021)
  • K200811 — cobas u 701 microscopy analyzer (November 6, 2020)
  • K171883 — Sysmex UF-5000 Fully Automated Urine Particle Analyzer (April 23, 2018)
  • K093861 — IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE (February 5, 2010)
  • K083002 — SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER (February 3, 2009)
  • K080887 — SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE (May 2, 2008)
  • K070910 — SYSMEX MODEL UF1000I (May 25, 2007)
  • K053135 — SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER (January 4, 2006)