ACCU-CHEK ADVANTAGE MODULE


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K021513
Device Name ACCU-CHEK ADVANTAGE MODULE
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
p.o. box 50416
indianapolis, 
IN 
46250 -0457

Original Contact scott thiel
Regulation Number 862.1345
Classification Product Code
NBW  
Date Received 05/09/2002
Decision Date 06/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No