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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ige, antigen, antiserum, control
510(k) Number K010855
Device Name RANDOX IGE
Applicant
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN, CO. ANTRIM,  GB BT29 4QY
Applicant Contact PAULINE ARMSTRONG
Correspondent
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN, CO. ANTRIM,  GB BT29 4QY
Correspondent Contact PAULINE ARMSTRONG
Regulation Number866.5510
Classification Product Code
DGC  
Date Received03/22/2001
Decision Date 05/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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