510(k) DEN230092 ยท SBT Device To Detect Microbial Colonization Directly From Clinical Specimens.
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
| Applicant | Diasorin Molecular, LLC, Cypress CA, US |
| Decision | Unknown, Jul 15, 2024 |
| Received | Dec 28, 2023 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN230092
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.