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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioimmunoassay, angiotensin i and renin
510(k) Number K121944
Device Name LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
Original Applicant
DIASORIN, INC.
1951 northwestern ave.
p.o. box 285
stillwater,  MN  55082 0285
Original Contact mari meyer
Regulation Number862.1085
Classification Product Code
CIB  
Subsequent Product Code
JJX  
Date Received07/03/2012
Decision Date 01/01/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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