510(k) K202755 ยท QDZ Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
| Applicant | Diasorin Molecular, LLC, Cypress CA, US |
| Decision | Substantially Equivalent, Nov 5, 2022 |
| Received | Sep 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202755
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.