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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C4, Antigen, Antiserum, Control
510(k) Number K000468
Device Name RANDOX COMPLEMENT C4
Applicant
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN, BT29 4QY CO.
ANTRIM, N. IRELAND,  IR
Applicant Contact P ARMSTRONG
Correspondent
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN, BT29 4QY CO.
ANTRIM, N. IRELAND,  IR
Correspondent Contact P ARMSTRONG
Regulation Number866.5240
Classification Product Code
DBI  
Date Received02/11/2000
Decision Date 03/27/2000
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
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