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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 K121746
Device Name RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
Original Applicant
RANDOX LABORATORIES, LTD.
55 diamond rd.
crumlin, county antrim,  GB bt29 4qy
Original Contact pauline armstrong
Regulation Number862.1660
Classification Product Code
JJX  
Date Received06/14/2012
Decision Date 07/11/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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