GO GLUCOSE MONITORING SYSTEM


Device Classification Name

glucose oxidase, glucose

510(k) Number K991754
Device Name GO GLUCOSE MONITORING SYSTEM
Applicant
LXN CORP.
6325 lusk blvd.
san diego, 
CA 
92121

Applicant Contact neda rashti
Correspondent
LXN CORP.
6325 lusk blvd.
san diego, 
CA 
92121

Correspodent Contact neda rashti
Regulation Number 862.1345
Classification Product Code
CGA  
Date Received 05/24/1999
Decision Date 09/08/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No