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510(k) K050235

IQ 200 URINE ANALYZER BODY FLUIDS MODULE by Iris International, Inc. — Product Code GKL

K050235 is an FDA 510(k) premarket notification submitted by Iris International, Inc. for the device "IQ 200 URINE ANALYZER BODY FLUIDS MODULE". The FDA issued a decision of Substantially Equivalent on March 23, 2005. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Iris International, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2005
Date Received
February 1, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Cell, Automated (Particle Counter)
Device Class
Class II
Regulation Number
864.5200
Review Panel
HE
Submission Type

Other clearances by Iris International, Inc.

  • K093861 — IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE (February 5, 2010)
  • K060280 — ICHEM 100 URINE CHEMISTRY ANALYZER (June 13, 2006)

Other clearances for product code GKL

  • K152776 — Glocyte Automated Cell Counter System (May 27, 2016)
  • K091539 — IQ 200 URINE ANALIZER BODY FLUIDS MODULE (August 31, 2010)
  • K071652 — HEMOCUE WBC SYSTEM (October 25, 2007)
  • K051693 — MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM (December 7, 2005)
  • K032677 — SYSMEX POCH-100I (February 11, 2004)
  • K022331 — ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD (September 11, 2002)
  • K001683 — SYSMEX R-500 (August 21, 2000)
  • K991070 — COULTER Z2 ANALYZER (May 11, 1999)
  • K981950 — SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 (November 3, 1998)
  • K981761 — SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER (August 14, 1998)

FDA data resources