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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Dehydrogenase, Glucose
510(k) Number K001993
Device Name SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS
Applicant
Abbott Laboratories
4-A Crosby Dr.
Bedford,  MA  01730
Applicant Contact JOE MAGLIOZZI
Correspondent
Abbott Laboratories
4-A Crosby Dr.
Bedford,  MA  01730
Correspondent Contact JOE MAGLIOZZI
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Code
NBW  
Date Received06/29/2000
Decision Date 11/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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