Device Classification Name |
prescription use blood glucose meter for near-patient testing
|
510(k) Number |
K163490 |
Device Name |
StatStrip Xpress 2 Glucose Hospital Meter System |
Applicant |
Nova Biomedical Corporation |
200 Prospect Street |
Waltham,
MA
02454
|
|
Applicant Contact |
Paul W. MacDonald |
Correspondent |
Nova Biomedical Corporation |
200 Prospect Street |
Waltham,
MA
02454
|
|
Correspondent Contact |
Paul W. MacDonald |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 12/12/2016 |
Decision Date | 01/06/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|