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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K003346
Device Name RANDOX GLUCOSE (GOD/PAP)
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 Number862.1345
Classification Product Code
CGA  
Date Received10/25/2000
Decision Date 03/15/2001
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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