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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K951222
Device Name TOTAL PROTEIN (URINE)
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 Number862.1645
Classification Product Code
JIR  
Date Received03/20/1995
Decision Date 04/24/1996
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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