The following data is part of a premarket notification filed by Luminex Molecular Diagnostics, Inc. with the FDA for Xtag Gastrointestinal Pathogen Panel (gpp)/xtag Data Analysis Software For Gpp (tdas Gpp).
| Device ID | K140377 |
| 510k Number | K140377 |
| Device Name: | XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) |
| Classification | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. Toronto, Ontario, CA M5g 1y8 |
| Contact | Tina Ip |
| Correspondent | Tina Ip LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. Toronto, Ontario, CA M5g 1y8 |
| Product Code | PCH |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-14 |
| Decision Date | 2014-09-16 |
| Summary: | summary |