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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name acid, uric, uricase (u.v.)
510(k) Number K033278
Device Name RANDOX URIC ACID
Applicant
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM,  GB BT29 4QY
Applicant Contact LYNNE HAMILTON
Correspondent
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM,  GB BT29 4QY
Correspondent Contact LYNNE HAMILTON
Regulation Number862.1775
Classification Product Code
CDO  
Date Received10/10/2003
Decision Date 02/27/2004
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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