ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K081389
Device Name ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46256

Applicant Contact scott thiel
Correspondent
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46256

Correspodent Contact scott thiel
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received 05/19/2008
Decision Date 07/15/2008
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