The following data is part of a premarket notification filed by Luminex Molecular Diagnostics, Inc. with the FDA for Xtag Respiratory Viral Panel.
| Device ID | K081483 |
| 510k Number | K081483 |
| Device Name: | XTAG RESPIRATORY VIRAL PANEL |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. Toronto, Ontario, CA M5g 1y8 |
| Contact | Gloria Lee |
| Correspondent | Gloria Lee LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. Toronto, Ontario, CA M5g 1y8 |
| Product Code | OCC |
| Subsequent Product Code | OEM |
| Subsequent Product Code | OEP |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-28 |
| Decision Date | 2008-06-25 |
| Summary: | summary |