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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 K160062
Device Name AUTION ELEVEN Semi-Automated Urinalysis System
Applicant
Arkray, Inc.
Yousuien-Nai 59 Gansuin-Cho
Kamigyo-Ku,  JP 602-0008
Applicant Contact Tom Speikers (U.S. Agent)
Correspondent
Arkray, Inc.
5182 76th St.
Edina,  MN  55439
Correspondent Contact Naveen Thuramalla
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JIN   JIO   JIR  
JJB   JMT   JRE   KQO   LJX  
Date Received01/12/2016
Decision Date 10/07/2016
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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