Device Classification Name |
gastrointestinal pathogen panel multiplex nucleic acid-based assay system
|
De Novo Number |
DEN130003 |
510(K) Number |
K121454
|
Device Name |
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) |
Requester |
luminex molecular diagnostics, inc. |
439 university ave. |
suite 900 |
toronto,
CA
m5g 1y8
|
|
Contact |
lubna syed |
|
Regulation Number | 866.3990
|
Classification Product Code |
|
Date Received | 01/11/2013 |
Decision Date | 01/14/2013 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Microbiology
|
Review Advisory Committee |
Microbiology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|