510(k) K190515 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Aptima Combo 2 Assay (Panther System)
| Applicant | Hologic, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, May 23, 2019 |
| Received | Mar 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190515
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.