Device Classification Name |
alpha-d-galactosidase a (gla) newborn screening test system
|
De Novo Number |
DEN150035 |
Device Name |
SEEKER System |
Requester |
baebies, inc. |
615 davis drive, |
po box 14403 |
durham,
NC
27709
|
|
Contact |
vamsee pamula |
|
Regulation Number | 862.1488
|
Classification Product Code |
|
Date Received | 08/05/2015 |
Decision Date | 02/03/2017 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Clinical Chemistry
|
Review Advisory Committee |
Clinical Chemistry
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|