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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name urinalysis controls (assayed and unassayed)
510(k) Number K110846
Device Name RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
Applicant
RANDOX LABORATORIES LIMITED
55 DIAMOND ROAD CRUMLIN
CRUMLIN ANTRIM,  GB BT29 4QY
Applicant Contact PAULINE ARMSTRONG
Correspondent
RANDOX LABORATORIES LIMITED
55 DIAMOND ROAD CRUMLIN
CRUMLIN ANTRIM,  GB BT29 4QY
Correspondent Contact PAULINE ARMSTRONG
Regulation Number862.1660
Classification Product Code
JJW  
Date Received03/28/2011
Decision Date 09/30/2011
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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