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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 K943463
Device Name THE YELLOW IRIS
Applicant
Intl. Remote Imaging Systems
9162 Eton Ave.
Chatsworth,  CA  91311
Applicant Contact SANFORD WIDRAN
Correspondent
Intl. Remote Imaging Systems
9162 Eton Ave.
Chatsworth,  CA  91311
Correspondent Contact SANFORD WIDRAN
Regulation Number862.2900
Classification Product Code
KQO  
Date Received07/18/1994
Decision Date 09/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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