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510(k) K823040

PATHOLOGY INSTRUMENTATION & ACCESSORIES by Iris Remote Imaging Systems — Product Code IBJ

K823040 is an FDA 510(k) premarket notification submitted by Iris Remote Imaging Systems for the device "PATHOLOGY INSTRUMENTATION & ACCESSORIES". The FDA issued a decision of Substantially Equivalent on January 14, 1983. The device falls under product code IBJ (Light, Microscope), a Class I device regulated under 21 CFR 864.3600.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1983
Date Received
October 14, 1982
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 for product code IBJ

  • K874750 — VIDEO ANALYZER 4000 (April 25, 1988)
  • K874190 — CELL COUNTING GRID GRATICULE (January 5, 1988)
  • K874207 — THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION (January 5, 1988)
  • K864049 — MCARTHUR MICROSCOPE, STANDARD METAL VERSION (October 29, 1986)
  • K854735 — MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. (December 10, 1985)
  • 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