BECTON DICKINSON DIABETES SOFTWARE


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K023219
Device Name BECTON DICKINSON DIABETES SOFTWARE
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 Code
JQP  
Date Received 09/26/2002
Decision Date 12/06/2002
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