510(k) K253756 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
cobas liat CT/NG nucleic acid test
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, May 15, 2026 |
| Received | Nov 25, 2025 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K253756
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.