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510(k) K093861

IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE by Iris International, Inc. — Product Code LKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2010
Date Received
December 16, 2009
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 Iris International, Inc.

  • K060280 — ICHEM 100 URINE CHEMISTRY ANALYZER (June 13, 2006)
  • K050235 — IQ 200 URINE ANALYZER BODY FLUIDS MODULE (March 23, 2005)

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  • 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)