MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING


Device Classification Name

glucose dehydrogenase, glucose

510(k) Number K022941
Device Name MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING
Original Applicant
ABBOTT LABORATORIES
4-a crosby dr.
bedford, 
MA 
01730 -1402

Original Contact joseph magliozzi
Regulation Number 862.1345
Classification Product Code
LFR  
Subsequent Product Code
NBW  
Date Received 09/03/2002
Decision Date 10/28/2002
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