510(k) DEN180047 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Aptima Mycoplasma genitalium Assay
| Applicant | Hologic, Inc., San Diego CA, US |
| Decision | Unknown, Jan 23, 2019 |
| Received | Aug 31, 2018 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN180047
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.