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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Cell, Automated (Particle Counter)
510(k) Number K934539
Device Name THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY
Applicant
Intl. Remote Imaging Systems
9162 Eton Ave.
Chatsworth,  CA  91311
Applicant Contact KENNETH LANGFORD
Correspondent
Intl. Remote Imaging Systems
9162 Eton Ave.
Chatsworth,  CA  91311
Correspondent Contact KENNETH LANGFORD
Regulation Number864.5200
Classification Product Code
GKL  
Date Received09/17/1993
Decision Date 03/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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