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510(k) K252580

iQ200 Series by Beckman Coulter, Inc. — Product Code LKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2025
Date Received
August 15, 2025
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

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Other clearances for product code LKM

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  • 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)
  • K022774 — IQ 200 SYSTEM (October 21, 2002)