510(k) K220321 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris
| Applicant | Hologic, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 3, 2022 |
| Received | Feb 3, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K220321
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.