CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER


Device Classification Name

glucose dehydrogenase, glucose

510(k) Number K110894
Device Name CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
Applicant
BAYER HEALTHCARE
430 south beiger street
mishawaka, 
IN 
46544

Applicant Contact roger sonnenburg
Correspondent
BAYER HEALTHCARE
430 south beiger street
mishawaka, 
IN 
46544

Correspodent Contact roger sonnenburg
Regulation Number 862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JJX   NBW  
Date Received 03/30/2011
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 NCT01268267NCT01268488
Reviewed by Third Party No

Combination Product

No