IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K103544
Device Name IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D
Applicant
AGAMATRIX INC
7c raymond ave
salem, 
NH 
03079

Applicant Contact william h mcgrail
Correspondent
AGAMATRIX INC
7c raymond ave
salem, 
NH 
03079

Correspodent Contact william h mcgrail
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX   JQP  
Date Received 12/02/2010
Decision Date 12/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No