ACCU-CHEK COMPACT SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K022171
Device Name ACCU-CHEK COMPACT SYSTEM
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Original Contact scott thiel
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received 07/03/2002
Decision Date 07/23/2002
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

Recalls CDRH Recalls