510(k) K170284 ยท OZZ Bordetella Pertussis Dna Assay System
Great Basin Bordetella Direct Test
| Applicant | Great Basin Scientific, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 31, 2017 |
| Received | Jan 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170284
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.