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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name uranyl acetate/zinc acetate, sodium
510(k) Number K043268
Device Name SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2
Applicant
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM,  GB BT29 4QY
Applicant Contact P ARMSTRONG
Correspondent
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM,  GB BT29 4QY
Correspondent Contact P ARMSTRONG
Regulation Number862.1665
Classification Product Code
CEI  
Subsequent Product Code
JIT  
Date Received11/26/2004
Decision Date 02/15/2005
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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