510(k) K180041 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
BioCode Gastrointestinal Pathogen Panel (GPP)
| Applicant | Applied BioCode, Inc., Santa Fe Springs CA, US |
| Decision | Substantially Equivalent, Sep 28, 2018 |
| Received | Jan 5, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180041
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.