PERSONAL GLUCOSE CONTROL CHARTING SYSTEM


information about

Device Classification Name

glucose oxidase, glucose

510(k) Number K002688
Device Name PERSONAL GLUCOSE CONTROL CHARTING SYSTEM
Original Applicant
LXN CORP.
6325 lusk blvd.
san diego, 
CA 
92121

Original Contact sandra f selvaggi
Regulation Number 862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received 08/29/2000
Decision Date 02/01/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No