Device Classification Name |
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
|
510(k) Number |
K121894 |
Device Name |
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX |
Applicant |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. |
SUITE 900 |
TORONTO,
CA
M5G 1Y8
|
|
Applicant Contact |
LUBNA SYED |
Correspondent |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. |
SUITE 900 |
TORONTO,
CA
M5G 1Y8
|
|
Correspondent Contact |
LUBNA SYED |
Regulation Number | 866.3990
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/29/2012 |
Decision Date | 03/21/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01326013
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|