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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Urinalysis System
510(k) Number K972141
Device Name THE YELLOW IRIS URINALYSIS WORKSTATION
Applicant
Intl. Remote Imaging Systems
9162 Eton Ave.
Chatsworth,  CA  91311
Applicant Contact FRED H DEINDOERFER
Correspondent
Intl. Remote Imaging Systems
9162 Eton Ave.
Chatsworth,  CA  91311
Correspondent Contact FRED H DEINDOERFER
Regulation Number862.2900
Classification Product Code
KQO  
Date Received06/06/1997
Decision Date 08/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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