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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Mixture
510(k) Number K012318
Device Name RANDOX THERAPEUTIC DRUG CALIBRATOR
Applicant
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin, Co. Antrim,  GB BT29 4QY
Applicant Contact P ARMSTRONG
Correspondent
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin, Co. Antrim,  GB BT29 4QY
Correspondent Contact P ARMSTRONG
Regulation Number862.3200
Classification Product Code
DKB  
Date Received07/23/2001
Decision Date 09/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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