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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 K954447
Device Name C-REACTIVE PROTEIN LATEX KIT
Applicant
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin,  IE BT29 4QY
Applicant Contact John Lamont
Correspondent
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin,  IE BT29 4QY
Correspondent Contact John Lamont
Regulation Number866.5270
Classification Product Code
DCK  
Date Received09/25/1995
Decision Date 12/18/1995
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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