| Device Classification Name |
gastrointestinal pathogen panel multiplex nucleic acid-based assay system
|
|---|
| 510(K) Number |
K121454 |
|---|
| Models |
1032C0316,
S032-0259
|
| Device Name |
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) |
|---|
| Applicant |
| LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| 439 university ave. |
| suite 900 |
|
toronto,
|
|
| Contact |
lubna syed |
| Regulation Number | 866.3990
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 05/16/2012 |
|---|
| Decision Date | 01/14/2013 |
|---|
| Decision |
de novo petitions granted (AN) |
|---|
| Classification Advisory Committee |
Microbiology
|
|---|
| Review Advisory Committee |
Microbiology
|
|---|
| FOI Item |
Approval Letter
|
| FDA Review |
Decision Summary
|
|---|
| Type |
De Novo Petitions Granted
|
|---|
| Clinical Trials |
NCT01326013
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
