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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igm, Antigen, Antiserum, Control
510(k) Number K955797
Device Name IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
Applicant
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin,  IE BT29 4QY
Applicant Contact JULIE TAYLOR
Correspondent
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin,  IE BT29 4QY
Correspondent Contact JULIE TAYLOR
Regulation Number866.5550
Classification Product Code
DFT  
Date Received12/22/1995
Decision Date 04/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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