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510(k) K874207

THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION by Intl. Remote Imaging Systems — Product Code IBJ

K874207 is an FDA 510(k) premarket notification submitted by Intl. Remote Imaging Systems for the device "THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION". The FDA issued a decision of Substantially Equivalent on January 5, 1988. The device falls under product code IBJ (Light, Microscope), a Class I device regulated under 21 CFR 864.3600. Intl. Remote Imaging Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1988
Date Received
October 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Microscope
Device Class
Class I
Regulation Number
864.3600
Review Panel
PA
Submission Type

Other clearances by Intl. Remote Imaging Systems

  • K022774 — IQ 200 SYSTEM (October 21, 2002)
  • K000373 — 939UDX URINE PATHOLOGY SYSTEM (April 14, 2000)
  • 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)
  • 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 IBJ

  • K874750 — VIDEO ANALYZER 4000 (April 25, 1988)
  • K874190 — CELL COUNTING GRID GRATICULE (January 5, 1988)
  • K864049 — MCARTHUR MICROSCOPE, STANDARD METAL VERSION (October 29, 1986)
  • K854735 — MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. (December 10, 1985)
  • K823040 — PATHOLOGY INSTRUMENTATION & ACCESSORIES (January 14, 1983)
  • K822207 — 2XC MICROSCOPE (August 5, 1982)
  • K821865 — A O MICROSCOPE VIDEO SYSTEM (July 14, 1982)
  • K802818 — PULLEN POCKET SCOPE (April 17, 1981)

FDA data resources