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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 K864282
Device Name GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA
Applicant
Medical Device Consultants, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact WILLIAM MORTON
Correspondent
Medical Device Consultants, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact WILLIAM MORTON
Regulation Number862.1345
Classification Product Code
CGA  
Date Received10/30/1986
Decision Date 05/26/1987
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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