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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Bilirubin
510(k) Number K152344
Device Name Total Bilirubin
Applicant
Randox Laboratories Limited
55 Diamond Rd., Ardmore
Crumlin, County Antrim,  GB BT29 4QY
Applicant Contact PAULINE ARMSTRONG
Correspondent
Randox Laboratories Limited
55 Diamond Rd., Ardmore
Crumlin, County Antrim,  GB BT29 4QY
Correspondent Contact PAULINE ARMSTRONG
Regulation Number862.1110
Classification Product Code
JFM  
Date Received08/19/2015
Decision Date 01/28/2016
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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