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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 K983504
Device Name PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST
Applicant
Medisense, Inc.
4-A Crosby Dr.
Bedford,  MA  01730 -1402
Applicant Contact MICHAEL HALPIN
Correspondent
Medisense, Inc.
4-A Crosby Dr.
Bedford,  MA  01730 -1402
Correspondent Contact MICHAEL HALPIN
Regulation Number862.1345
Classification Product Code
CGA  
Date Received10/06/1998
Decision Date 07/09/1999
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
Recalls CDRH Recalls
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