PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY


Device Classification Name

glucose dehydrogenase, glucose

510(k) Number K021960
Device Name PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
Original Applicant
ABBOTT LABORATORIES
4-a crosby dr.
bedford, 
MA 
01730 -1402

Original Contact janet s connolly
Regulation Number 862.1345
Classification Product Code
LFR  
Date Received 06/14/2002
Decision Date 08/16/2002
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