SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS


information about

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
Original Applicant
ABBOTT LABORATORIES
4-a crosby dr.
bedford, 
MA 
01730 -1402

Original Contact joe magliozzi
Regulation Number 862.1345
Classification Product Code
LFR  
Subsequent Product Code
NBW  
Date Received 06/29/2000
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