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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Turbidimetric Method, Lipoproteins
510(k) Number K950383
Device Name APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT
Applicant
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin, Co. Antrim,  IE BT29 4QY
Applicant Contact John Lamont
Correspondent
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin, Co. Antrim,  IE BT29 4QY
Correspondent Contact John Lamont
Regulation Number862.1475
Classification Product Code
JHN  
Date Received01/31/1995
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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