510(k) K163184 · LSL Dna-Reagents, Neisseria
cobas® CT/NG v2.0 Test
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Feb 9, 2017 |
| Received | Nov 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163184
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.