510(k) K182703 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
EntericBio Dx Assay
| Applicant | Serosep , Ltd., Annacotty, IE |
| Decision | Substantially Equivalent, Jun 19, 2019 |
| Received | Sep 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182703
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.