Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K122338 |
Device Name |
PREFERRED BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
PRODIGY DIABETES CARE, LLC |
1468 Harwell Avenue |
Crofton,
MD
21114
|
|
Applicant Contact |
E.J. Smith |
Correspondent |
PRODIGY DIABETES CARE, LLC |
1468 Harwell Avenue |
Crofton,
MD
21114
|
|
Correspondent Contact |
E.J. Smith |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/02/2012 |
Decision Date | 11/05/2013 |
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
|
|
|