Device Classification Name |
menopause test system
|
De Novo Number |
DEN180004 |
Device Name |
picoAMH ELISA |
Requester |
ansh labs llc |
445 medical center blvd. |
webster,
TX
77598
|
|
Contact |
ajay kumar |
|
Regulation Number | 862.1093
|
Classification Product Code |
|
Date Received | 01/22/2018 |
Decision Date | 10/24/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Clinical Chemistry
|
Review Advisory Committee |
Toxicology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|