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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Urine Particle
510(k) Number K022774
Device Name IQ 200 SYSTEM
Applicant
Intl. Remote Imaging Systems
9162 Eton Ave.
Chatsworth,  CA  91311
Applicant Contact HARVEY L KASDAN
Correspondent
Intl. Remote Imaging Systems
9162 Eton Ave.
Chatsworth,  CA  91311
Correspondent Contact HARVEY L KASDAN
Regulation Number864.5200
Classification Product Code
LKM  
Subsequent Product Code
KQO  
Date Received08/21/2002
Decision Date 10/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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