510(k) K242109 · QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
| Applicant | Cepheid®, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jan 15, 2025 |
| Received | Jul 19, 2024 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K242109
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.