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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 K101852
Device Name CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
Applicant
Iris International Inc., A Division of Iris Iris I
9172 Eton Ave.
Chatsworth,  CA  91311
Applicant Contact DAVID W GATES
Correspondent
Iris International Inc., A Division of Iris Iris I
9172 Eton Ave.
Chatsworth,  CA  91311
Correspondent Contact DAVID W GATES
Regulation Number862.2900
Classification Product Code
KQO  
Subsequent Product Codes
CDM   CEN   JIL   JIN   JIO  
JIR   JJB   JMA   JMT   JRE   LJX  
Date Received07/01/2010
Decision Date 03/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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