510(k) DEN180040 ยท QDZ Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
| Applicant | Meridian Bioscience, Inc., Cincinnati OH, US |
| Decision | Unknown, Nov 30, 2018 |
| Received | Jul 30, 2018 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN180040
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.