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510(k) K953116

WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER by Intl. Remote Imaging Systems — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1996
Date Received
July 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

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  • 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)
  • K914256 — YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU (May 1, 1992)
  • K893530 — IRISTAIN FORMULA 2, PARTS 1 AND 2 (June 13, 1989)
  • K874207 — THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION (January 5, 1988)

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