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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Purple Dye-Binding, Albumin
510(k) Number K000483
Device Name RANDOX ALBUMIN
Applicant
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin, Co. Antrim,  IE BT29 4QY
Applicant Contact P ARMSTRONG
Correspondent
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin, Co. Antrim,  IE BT29 4QY
Correspondent Contact P ARMSTRONG
Regulation Number862.1035
Classification Product Code
CJW  
Date Received02/14/2000
Decision Date 03/31/2000
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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