510(k) K173498 ยท OZZ Bordetella Pertussis Dna Assay System
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
| Applicant | Diasorin Molecular, LLC, Cypress CA, US |
| Decision | Substantially Equivalent, Aug 13, 2018 |
| Received | Nov 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173498
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.