NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K112638
Device Name NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS
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
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received 09/09/2011
Decision Date 03/09/2012
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