510(k) K874207

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

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