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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K001009
Device Name RANDOX C-REACTIVE PROTEIN
Applicant
Randox Laboratories, Ltd.
Ardmore, 55 Diamond Rd.
Crumlin, Co. Antrim,  GB BT29 4QY
Applicant Contact P. ARMSTRONG
Correspondent
Randox Laboratories, Ltd.
Ardmore, 55 Diamond Rd.
Crumlin, Co. Antrim,  GB BT29 4QY
Correspondent Contact P. ARMSTRONG
Regulation Number866.5270
Classification Product Code
DCK  
Date Received03/29/2000
Decision Date 08/04/2000
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
Recalls CDRH Recalls
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