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) Luminex Magpix.
| Device ID | K121894 |
| 510k Number | K121894 |
| Device Name: | XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX |
| Classification | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. SUITE 900 Toronto, CA M5g 1y8 |
| Contact | Lubna Syed |
| Correspondent | Lubna Syed LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. SUITE 900 Toronto, CA M5g 1y8 |
| Product Code | PCH |
| Subsequent Product Code | JJH |
| Subsequent Product Code | NSU |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-29 |
| Decision Date | 2013-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840487101421 | K121894 | 000 |
| 00840487100288 | K121894 | 000 |
| 00840487100271 | K121894 | 000 |
| 00840487100264 | K121894 | 000 |