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510(k) K012372

SYSMEX UF-50 by Sysmex Corp. — Product Code LKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2001
Date Received
July 26, 2001
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 Sysmex Corp.

  • K992875 — SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER (November 9, 1999)
  • K981950 — SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 (November 3, 1998)
  • K981761 — SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER (August 14, 1998)
  • K971736 — SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER (August 26, 1997)
  • K964946 — SYSMEX CA-1000/SYSMEX CA-5000 (March 18, 1997)
  • K964375 — SYSMEX SE/RAM-1 (March 13, 1997)
  • K961054 — SYSMEX UF-100 (October 28, 1996)
  • K950508 — SYSMEX SF-3000 (November 3, 1995)
  • K945837 — SYSMEX(TM) F-820, 520 (June 9, 1995)
  • K942097 — TOA MEDICAL ELECTRONICS CA-5000 (March 24, 1995)

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  • 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)