510(k) K183530 ยท ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
TruDiagnosis System
| Applicant | Akonni Biosystems, Inc., Frederick MD, US |
| Decision | Substantially Equivalent, May 24, 2019 |
| Received | Dec 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183530
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.