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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K162275
Device Name Randox RX Daytona Plus Alkaline Phosphatase (ALP)
Applicant
Randox Laboratories Limited
55 Diamond Rd.
Crumlin,  GB BT29 4QY
Applicant Contact Pauline Armstrong
Correspondent
Randox Laboratories Limited
55 Diamond Rd.
Crumlin,  GB BT29 4QY
Correspondent Contact Pauline Armstrong
Regulation Number862.1050
Classification Product Code
CJE  
Date Received08/12/2016
Decision Date 04/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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