NOVA ONE BLOOD GLUCOSE MONITOR


Device Classification Name

glucose dehydrogenase, glucose

510(k) Number K122435
Device Name NOVA ONE BLOOD GLUCOSE MONITOR
Applicant
NOVA BIOMEDICAL CORPORATION
200 prospect st
waltham, 
MA 
02454

Applicant Contact paul w macdonald
Correspondent
NOVA BIOMEDICAL CORPORATION
200 prospect st
waltham, 
MA 
02454

Correspodent Contact paul w macdonald
Regulation Number 862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JJX   NBW  
Date Received 08/10/2012
Decision Date 12/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No