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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name single (specified) analyte controls (assayed and unassayed)
510(k) Number K121588
Models CYS5019, CYS5020
Device Name RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
Original Applicant
RANDOX LABORATORIES, LTD.
55 diamond rd.
crumlin, county antrim,  UK bt29 4qy
Original Contact pauline armstrong
Regulation Number862.1660
Classification Product Code
JJX  
Date Received05/31/2012
Decision Date 06/20/2012
Decision substantially equivalent (SE)
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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