MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K072413
Device Name MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM
Applicant
AGAMATRIX
10 maor parkway
salem, 
NH 
03079

Applicant Contact connie hertel
Correspondent
AGAMATRIX
10 maor parkway
salem, 
NH 
03079

Correspodent Contact connie hertel
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received 08/28/2007
Decision Date 09/27/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No