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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 K960054
Device Name 900UDX URINE PATHOLOGY SYSTEM
Applicant
Intl. Remote Imaging Systems
9162 Eton Ave.
Chatsworth,  CA  91311
Applicant Contact ALAN E KOONTZ, PH.D.
Correspondent
Intl. Remote Imaging Systems
9162 Eton Ave.
Chatsworth,  CA  91311
Correspondent Contact ALAN E KOONTZ, PH.D.
Regulation Number862.2900
Classification Product Code
KQO  
Date Received01/04/1996
Decision Date 03/22/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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