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 | K152386 |
| 510k Number | K152386 |
| 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 | Tina Ip |
| Correspondent | Tina Ip LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVENUE Toronto, CA M5g 1y8 |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-24 |
| Decision Date | 2015-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840487100417 | K152386 | 000 |
| 00840487100448 | K152386 | 000 |