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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,  GA BT29 4QY
Applicant Contact PAULINE ARMSTRONG
Correspondent
RANDOX LABORATORIES LIMITED
34 DIAMOND ROAD
CRUMLIN ANTRIM,  GA BT29 4QY
Correspondent Contact PAULINE ARMSTRONG
Regulation Number862.1150
Classification Product Code
JIS  
Date Received07/18/2012
Decision Date 08/14/2012
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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