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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, primary
510(K) Number K122126
Device Name DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
Applicant
RANDOX LABORATORIES LIMITED
34 diamond road
crumlin antrim, 
Contact pauline armstrong
Regulation Number862.1150
Classification Product Code
JIS  
Date Received07/18/2012
Decision Date 08/14/2012
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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