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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Microscope
510(k) Number K874207
Device Name THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION
Applicant
Intl. Remote Imaging Systems
9162 Eton Ave.
Chatsworth,  CA  91311
Applicant Contact KASDEN, PHD
Correspondent
Intl. Remote Imaging Systems
9162 Eton Ave.
Chatsworth,  CA  91311
Correspondent Contact KASDEN, PHD
Regulation Number864.3600
Classification Product Code
IBJ  
Date Received10/15/1987
Decision Date 01/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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