Device Classification Name |
prescription use blood glucose meter for near-patient testing
|
510(k) Number |
K150281 |
Device Name |
StatStrip Glucose Hospital Meter |
Applicant |
NOVA BIOMEDICAL CORPORATION |
200 PROSPECT STREET |
WALTHAM,
MA
02454 -9141
|
|
Applicant Contact |
Paul W. MacDonald |
Correspondent |
NOVA BIOMEDICAL CORPORATION |
200 PROSPECT STREET |
WALTHAM,
MA
02454 -9141
|
|
Correspondent Contact |
Paul W. MacDonald |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 02/05/2015 |
Decision Date | 05/06/2015 |
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
|