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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 K882262
Device Name GLUCOSE-SUPER FAST 4983050 AND 4983500
Applicant
American Research Products Co.
30175 Solon Industrial Pkwy.
P.O. Box 39098
Solon,  OH  44139
Applicant Contact DIANNE EICH
Correspondent
American Research Products Co.
30175 Solon Industrial Pkwy.
P.O. Box 39098
Solon,  OH  44139
Correspondent Contact DIANNE EICH
Regulation Number862.1345
Classification Product Code
CGA  
Date Received05/31/1988
Decision Date 02/02/1989
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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