510(k) DEN130003 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)
| Applicant | Luminex Molecular Diagnostics, Inc., Toronto, CA |
| Decision | Unknown, Jan 14, 2013 |
| Received | Jan 11, 2013 |
| Type | Post-NSE |
| FDA record | Open on fda.gov |
Recalls that name DEN130003
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.