The following data is part of a premarket notification filed by Luminex Molecular Diagnostics, Inc. with the FDA for Nxtag Respiratory Pathogen Panel, Nxtag Respiratory Pathogen Panel Files, Synct Software.
| Device ID | K193167 |
| 510k Number | K193167 |
| Device Name: | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | Luminex Molecular Diagnostics, Inc. 439 University Avenue Toronto, CA M5g 1y8 |
| Contact | Jennifer Grimes |
| Correspondent | Jennifer Grimes Luminex Molecular Diagnostics, Inc. 439 University Avenue Toronto, CA M5g 1y8 |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-15 |
| Decision Date | 2019-12-11 |