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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 K984527
Device Name IN TOUCH DIABETES MANAGEMENT SOFTWARE
Applicant
Lifescan, Inc.
1000 Gibraltar Dr.
Milpitas,  CA  95035 -6312
Applicant Contact LORI CONZEN
Correspondent
Lifescan, Inc.
1000 Gibraltar Dr.
Milpitas,  CA  95035 -6312
Correspondent Contact LORI CONZEN
Regulation Number862.1345
Classification Product Code
CGA  
Date Received12/21/1998
Decision Date 04/29/1999
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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