510(k) K183223 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, Dec 19, 2018 |
| Received | Nov 20, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183223
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.