Device Classification Name |
plazomicin test system, immunoassay
|
De Novo Number |
DEN180030 |
Device Name |
QMS Plazomicin Immunoassay |
Requester |
microgenics corporation |
46500 kato road |
fremont,
CA
94538
|
|
Contact |
minoti patel |
|
Regulation Number | 862.3460
|
Classification Product Code |
|
Date Received | 06/25/2018 |
Decision Date | 11/19/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Toxicology
|
Review Advisory Committee |
Toxicology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|