CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

glucose dehydrogenase, glucose

510(k) Number K111268
Device Name CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
Applicant
BAYER HEALTHCARE
430 south beiger street
mishawaka, 
IN 
46544

Applicant Contact weiping zhong
Correspondent
BAYER HEALTHCARE
430 south beiger street
mishawaka, 
IN 
46544

Correspodent Contact weiping zhong
Regulation Number 862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JJX   NBW  
Date Received 05/04/2011
Decision Date 03/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01264016
Reviewed by Third Party No

Combination Product

No