TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K030703
Device Name TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS
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  
Date Received 03/06/2003
Decision Date 07/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls