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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K171083
Device Name iChemVELOCITY Automated Urine Chemistry System
Applicant
Iris Diagnostics, A Division of Iris International, Inc.
9172 Eton Ave.
Chatsworth,  CA  91311
Applicant Contact Nancy Nadler
Correspondent
Iris Diagnostics, A Division of Iris International, Inc.
9172 Eton Ave.
Chatsworth,  CA  91311
Correspondent Contact Nancy Nadler
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JIN   JIO   JIR  
JJB   JMA   JMT   JRE   KQO   LJX  
Date Received04/11/2017
Decision Date 05/12/2017
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
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