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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K130337
Model IAS3113, IAS3114, IAS3115
Device Name RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3
Original Applicant
RANDOX LABORATORIES LIMITED
55 diamond road
crumlin, antrim,  UK bt29 4qy
Original Contact pauline armstrong
Regulation Number862.1660
Classification Product Code
JJY  
Date Received03/01/2013
Decision Date 06/19/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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