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510(k) K232416

AUTION EYE AI-4510 Urine Particle Analysis System by Arkray, Inc. — Product Code LKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2024
Date Received
August 11, 2023
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

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  • K051432 — SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS (June 17, 2005)
  • K050790 — SPOTCHEM II LDH TEST (June 6, 2005)

Other clearances for product code LKM

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