Home / 510(k) Clearances / K914256

510(k) K914256

YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU by Intl. Remote Imaging Systems — Product Code GKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1992
Date Received
September 23, 1991
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

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  • K972141 — THE YELLOW IRIS URINALYSIS WORKSTATION (August 25, 1997)
  • K953116 — WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER (May 13, 1996)
  • K960054 — 900UDX URINE PATHOLOGY SYSTEM (March 22, 1996)
  • K954006 — YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY (March 12, 1996)
  • K943463 — THE YELLOW IRIS (September 20, 1994)
  • K934539 — THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABIL (March 30, 1994)
  • K893530 — IRISTAIN FORMULA 2, PARTS 1 AND 2 (June 13, 1989)
  • K874207 — THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION (January 5, 1988)

Other clearances for product code GKL

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  • 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)