510(k) K230451 · MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
Aptima® Chlamydia trachomatis Assay
| Applicant | Hologic, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 16, 2023 |
| Received | Feb 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230451
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.