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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 K121456
Model AU-4050
Device Name AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL
Original Applicant
ARKRAY, INC.
5182 west 76th street
edina,  MN  55439
Original Contact adam ettl
Regulation Number862.2900
Classification Product Code
KQO  
Subsequent Product Codes
CDM   CEN   JIL   JIN   JIO  
JIR   JJB   JJW   JMT   JRE   LJX  
LKM  
Date Received05/16/2012
Decision Date 02/01/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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