510(k) K173330 ยท PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
PanNAT STEC Test
| Applicant | Micronics, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Jun 1, 2018 |
| Received | Oct 23, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173330
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.