MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K021448
Device Name MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
p.o. box 50416
indianapolis, 
IN 
46250 -0457

Original Contact mike flis
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received 05/06/2002
Decision Date 06/03/2002
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