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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crystal Violet For Histology
510(k) Number K821503
Device Name IRIS URINE STAIN
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 Number864.1850
Classification Product Code
ICF  
Date Received05/19/1982
Decision Date 06/03/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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