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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 K001427
Device Name MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
Applicant
SELFCARE, INC.
200 PROSPECT ST.
WALTHAM,  MA  02154 -3457
Applicant Contact CAROL A ADILETTO
Correspondent
SELFCARE, INC.
200 PROSPECT ST.
WALTHAM,  MA  02154 -3457
Correspondent Contact CAROL A ADILETTO
Regulation Number862.1345
Classification Product Code
CGA  
Date Received05/05/2000
Decision Date 06/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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