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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urease And Glutamic Dehydrogenase, Urea Nitrogen
510(k) Number K923506
Device Name UREA KIT
Applicant
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin, Bt29 4qy Co.
Antrim, N. Ireland,  IR
Applicant Contact John Lamont
Correspondent
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin, Bt29 4qy Co.
Antrim, N. Ireland,  IR
Correspondent Contact John Lamont
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received07/15/1992
Decision Date 09/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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