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510(k) K091539

IQ 200 URINE ANALIZER BODY FLUIDS MODULE by Iris Diagnostics — Product Code GKL

K091539 is an FDA 510(k) premarket notification submitted by Iris Diagnostics for the device "IQ 200 URINE ANALIZER BODY FLUIDS MODULE". The FDA issued a decision of Substantially Equivalent on August 31, 2010. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Iris Diagnostics has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2010
Date Received
May 26, 2009
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 Diagnostics

  • K072640 — IRISPEC,CA/CB/CC (December 21, 2007)

Other clearances for product code GKL

  • K152776 — Glocyte Automated Cell Counter System (May 27, 2016)
  • K071652 — HEMOCUE WBC SYSTEM (October 25, 2007)
  • K051693 — MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM (December 7, 2005)
  • K050235 — IQ 200 URINE ANALYZER BODY FLUIDS MODULE (March 23, 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