Device Classification Name |
microbial colony image assessment system
|
De Novo Number |
DEN150059 |
Device Name |
APAS Compact with Urine Analysis Module |
Requester |
clever culture systems ag |
seestrasse 204a |
baech,
CH
8806
|
|
Contact |
lusia guthrie |
|
Regulation Number | 866.2190
|
Classification Product Code |
|
Date Received | 12/24/2015 |
Decision Date | 10/06/2016 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Microbiology
|
Review Advisory Committee |
Microbiology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|