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510(k) K821503

IRIS URINE STAIN by Intl. Remote Imaging Systems — Product Code ICF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1982
Date Received
May 19, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crystal Violet For Histology
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

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  • K954006 — YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY (March 12, 1996)
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  • K914256 — YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU (May 1, 1992)
  • K893530 — IRISTAIN FORMULA 2, PARTS 1 AND 2 (June 13, 1989)

Other clearances for product code ICF

  • K864531 — TISSUE GRAM STAIN (December 22, 1986)
  • K842537 — VON WILLEBRAND FACTOR ANTIGEN SCREEN (October 1, 1984)
  • K842730 — GENTIAN VIOLET (August 3, 1984)
  • K792495 — VOLU-SOL URINARY SEDIMENT STAIN (December 18, 1979)