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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 K901613
Device Name MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM
Applicant
Medisense, Inc.
128 Sidney St.
Cambridge,  MA  02139
Applicant Contact LIAS, PH.D.
Correspondent
Medisense, Inc.
128 Sidney St.
Cambridge,  MA  02139
Correspondent Contact LIAS, PH.D.
Regulation Number862.1345
Classification Product Code
CGA  
Date Received04/06/1990
Decision Date 07/10/1990
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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