510(k) K202408 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
cobas CTNG for use on cobas 6800/8800 systems
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Jan 21, 2021 |
| Received | Aug 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202408
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.