TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K080641
Device Name TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81
Applicant
HOME DIAGNOSTICS, INC.
2400 n.w. 55th ct.
fort lauderdale, 
FL 
33309

Applicant Contact karen devincent
Correspondent
HOME DIAGNOSTICS, INC.
2400 n.w. 55th ct.
fort lauderdale, 
FL 
33309

Correspodent Contact karen devincent
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received 03/06/2008
Decision Date 08/19/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No