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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 K041361
Device Name RANDOX TRI LEVEL CARDIAC CONTROL
Applicant
RANDOX LABORATORIES LIMITED
55 DIAMOND ROAD CRUMLIN
CO ANTRIM
CRUMLIN,  GB BT29 4QY
Applicant Contact PAULINE ARMSTRONG
Correspondent
RANDOX LABORATORIES LIMITED
55 DIAMOND ROAD CRUMLIN
CO ANTRIM
CRUMLIN,  GB BT29 4QY
Correspondent Contact PAULINE ARMSTRONG
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/21/2004
Decision Date 09/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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