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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 K022591
Device Name RANDOX LIPID CONTROL
Applicant
RANDOX LABORATORIES, LTD.
ardmore, diamond road
crumlin, co. antrim, 
Contact pauline armstrong
Regulation Number862.1660
Classification Product Code
JJY  
Date Received08/05/2002
Decision Date 08/30/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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