CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K121087
Device Name CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
Applicant
BAYER HEALTHCARE
430 south beiger st.
mishawaka, 
IN 
46544

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

Correspodent Contact roger sonnenburg
Regulation Number 862.1345
Classification Product Code
NBW  
Date Received 04/10/2012
Decision Date 06/28/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Clinical Trials NCT01466075
Reviewed by Third Party No

Combination Product

No