510(k) K140647 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, Oct 24, 2014 |
| Received | Mar 13, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140647
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.