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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name albumin, fitc, antigen, antiserum, control
510(k) Number K002674
Device Name RANDOX MICROALBUMIN
Applicant
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, CO. ANTRIM,  IE BT29 4QY
Applicant Contact PAULINE ARMSTRONG
Correspondent
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, CO. ANTRIM,  IE BT29 4QY
Correspondent Contact PAULINE ARMSTRONG
Regulation Number866.5040
Classification Product Code
DDZ  
Date Received08/28/2000
Decision Date 10/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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