CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)


Device Classification Name

glucose dehydrogenase, glucose

510(k) Number K110587
Device Name CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
Applicant
BAYER HEALTHCARE, LLC
555 white plains road
tarrytown, 
NY 
10591

Applicant Contact chuck ryan
Correspondent
BAYER HEALTHCARE, LLC
555 white plains road
tarrytown, 
NY 
10591

Correspodent Contact chuck ryan
Regulation Number 862.1345
Classification Product Code
LFR  
Subsequent Product Code
NBW  
Date Received 03/01/2011
Decision Date 03/28/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01328717
Reviewed by Third Party No

Combination Product

No