BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

glucose oxidase, glucose

510(k) Number K022580
Device Name BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
BECTON DICKINSON & CO.
1 becton dr.
franklin lakes, 
NJ 
07417 -1885

Original Contact peter zurlo
Regulation Number 862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received 08/05/2002
Decision Date 10/09/2002
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

Recalls CDRH Recalls