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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 K060280
Device Name ICHEM 100 URINE CHEMISTRY ANALYZER
Applicant
Iris International, Inc.
9172 Eton Ave.
Chatsworth,  CA  91311
Applicant Contact GERALD J HADDOCK
Correspondent
Iris International, Inc.
9172 Eton Ave.
Chatsworth,  CA  91311
Correspondent Contact GERALD J HADDOCK
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JIN   JIO   JIR  
JJB   JJQ   JMA   JMT   KQO   LJX  
Date Received02/02/2006
Decision Date 06/13/2006
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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