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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 K914256
Device Name YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU
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 Number864.5200
Classification Product Code
GKL  
Date Received09/23/1991
Decision Date 05/01/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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