510(k) K121894 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX
| Applicant | Luminex Molecular Diagnostics, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Mar 21, 2013 |
| Received | Jun 29, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121894
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.