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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Potassium
510(k) Number K052914
Device Name RX IMOLA
Applicant
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM,  GB BT29 4QY
Applicant Contact PAULINE ARMSTRONG
Correspondent
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM,  GB BT29 4QY
Correspondent Contact PAULINE ARMSTRONG
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGZ   JGJ   JGS   JJE  
Date Received10/14/2005
Decision Date 03/31/2006
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
Recalls CDRH Recalls
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