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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 K991480
Device Name EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
Applicant
Selfcare, Inc.
200 Prospect St.
Waltham,  MA  02154
Applicant Contact Carol Adiletto
Correspondent
Selfcare, Inc.
200 Prospect St.
Waltham,  MA  02154
Correspondent Contact Carol Adiletto
Regulation Number862.1345
Classification Product Code
CGA  
Date Received04/28/1999
Decision Date 09/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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