The following data is part of a premarket notification filed by Luminex Molecular Diagnostics, Inc. with the FDA for Xtag Respiratory Viral Panel Fast, Xtag Data Analysis Software For Rvp Fast.
| Device ID | K103776 |
| 510k Number | K103776 |
| Device Name: | XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. SUITE 900 Toronto, Ontario, CA M5g 1y8 |
| Contact | Lubna Syed |
| Correspondent | Lubna Syed LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. SUITE 900 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-27 |
| Decision Date | 2011-07-01 |
| Summary: | summary |