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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 K830220
Device Name YELLOW IRIS TM
Applicant
INTL. REMOTE IMAGING SYSTEMS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INTL. REMOTE IMAGING SYSTEMS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.2900
Classification Product Code
KQO  
Date Received01/24/1983
Decision Date 06/17/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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