510(k) K112199 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
| Applicant | Luminex Molecular Diagnostics, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Sep 1, 2011 |
| Received | Aug 1, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112199
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2019 | Luminex Molecular Diagnostics xTAG Respiratory Viral Panel (RVP):
Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111
in vitro diagnostic test Open, Classified |
OCC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.