Device Classification Name |
spinal muscular atrophy newborn screening test system
|
De Novo Number |
DEN200044 |
Device Name |
Eonis SCID-SMA Kit |
Requester |
perkinelmer inc. |
940 winter street |
waltham,
MA
02451
|
|
Contact |
casey fox |
|
Regulation Number | 866.5980
|
Classification Product Code |
|
Date Received | 07/08/2020 |
Decision Date | 11/09/2022 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Immunology
|
Review Advisory Committee |
Molecular Genetics
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|