510(k) K140377 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)
| Applicant | Luminex Molecular Diagnostics, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Sep 16, 2014 |
| Received | Feb 14, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140377
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2019 | Luminex Molecular Diagnostics xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human s Open, Classified |
PCH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.