Home / 510(k) Clearances / K080887

510(k) K080887

SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE by Sysmex America, Inc. — Product Code LKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2008
Date Received
March 31, 2008
Clearance Type
Special
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 Sysmex America, Inc.

  • K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer (June 25, 2025)
  • K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer (June 25, 2025)
  • K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000) (June 2, 2025)
  • K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (December 21, 2023)
  • K210346 — Sysmex XW-100 Automated Hematology Analyzer (November 8, 2022)
  • K182389 — Sysmex XN-L Automated Hematology Analyzer (January 25, 2019)
  • K182062 — Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device (October 30, 2018)
  • K171883 — Sysmex UF-5000 Fully Automated Urine Particle Analyzer (April 23, 2018)
  • K172604 — XW-100 Automated Hematology Analyzer for CLIA Waived Use (November 6, 2017)
  • K160538 — Sysmex XN-L Automated Hematology Analyzer (December 22, 2016)

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)
  • K070910 — SYSMEX MODEL UF1000I (May 25, 2007)
  • K053135 — SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER (January 4, 2006)
  • K022774 — IQ 200 SYSTEM (October 21, 2002)