510(k) K152285 ยท OZZ Bordetella Pertussis Dna Assay System
illumigene Pertussis DNA Amplification Assay
| Applicant | Meridian Bioscience, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Nov 10, 2015 |
| Received | Aug 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152285
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.