Device Classification Name |
Glucose Dehydrogenase, Glucose
|
510(k) Number |
K122688 |
Device Name |
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE 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
|
|
Correspondent Contact |
PAUL W MACDONALD |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/04/2012 |
Decision Date | 04/04/2013 |
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
|
|
|