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 (tdas Gpp).
| Device ID | K183030 |
| 510k Number | K183030 |
| Device Name: | XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP) |
| Classification | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | Luminex Molecular Diagnostics, Inc. 439 University Avenue Toronto, CA M5g 1y8 |
| Contact | Tina Ip |
| Correspondent | Tina Ip Luminex Molecular Diagnostics, Inc. 439 University Avenue Toronto, CA M5g 1y8 |
| Product Code | PCH |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-01 |
| Decision Date | 2018-11-30 |