Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K091547 |
Device Name |
NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS |
Applicant |
NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. |
WALTHAM,
MA
02454 -9141
|
|
Applicant Contact |
PAUL MACDONALD |
Correspondent |
NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. |
WALTHAM,
MA
02454 -9141
|
|
Correspondent Contact |
PAUL MACDONALD |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/27/2009 |
Decision Date | 01/15/2010 |
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
|
Recalls |
CDRH Recalls
|
|
|