510(k) K260917 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Jul 8, 2026 |
| Received | Mar 19, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260917
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.