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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 K140971
Device Name LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.
Applicant
RANDOX LABORATORIES LIMITED
55 DIAMOND RD.
CRUMLIN, CO.ANTRIM,  GB BT29 4QY
Applicant Contact PAULINE ARMSTRONG
Correspondent
RANDOX LABORATORIES LIMITED
55 DIAMOND RD.
CRUMLIN, CO.ANTRIM,  GB BT29 4QY
Correspondent Contact PAULINE ARMSTRONG
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/16/2014
Decision Date 12/08/2014
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
Recalls CDRH Recalls
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