BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K022581
Device Name BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
BECTON DICKINSON & CO.
1 becton dr.
franklin lakes, 
NJ 
07417 -1885

Original Contact john schalago
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
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