GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM


information about

Device Classification Name

glucose oxidase, glucose

510(k) Number K002621
Device Name GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
APEX BIOTECHNOLOGY CORP.
3600 holly ln. n.
suite 90
plymouth, 
MN 
55447

Original Contact steven crees
Regulation Number 862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received 08/23/2000
Decision Date 01/22/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls
Category: Uncategorized