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 |