510(k) K230267 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
NeuMoDx CT/NG Assay 2.0
| Applicant | Neumodx Molecular, Inc., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Dec 22, 2023 |
| Received | Jan 31, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230267
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.