510(k) K191160 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
| Applicant | Luminex Molecular Diagnostics, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Nov 4, 2019 |
| Received | May 1, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191160
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.