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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, secondary
510(k) Number K122177
Models CTUR-0610, PRTU-0022
Device Name ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
Original Applicant
ELITECHGROUP
21720 23rd dr se
suite 150
bothell,  WA  98021
Original Contact debra k hutson
Regulation Number862.1150
Classification Product Code
JIT  
Subsequent Product Code
JJX  
Date Received07/23/2012
Decision Date 02/15/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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