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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator/Data Processing Module, For Clinical Use
510(k) Number K983468
Device Name FASTTAKE ADAPTER, MODEL # P/N 020-072-01
Applicant
Selfcare, Inc.
200 Prospect St.
Waltham,  MA  02154
Applicant Contact BETTY LANE
Correspondent
Selfcare, Inc.
200 Prospect St.
Waltham,  MA  02154
Correspondent Contact BETTY LANE
Regulation Number862.2100
Classification Product Code
JQP  
Date Received10/01/1998
Decision Date 12/17/1998
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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