510(k) K152955 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Great Basin Shiga Toxin Direct Test
| Applicant | Great Basin Scientific, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 22, 2016 |
| Received | Oct 7, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152955
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.