510(k) K173887 ยท LSL Dna-Reagents, Neisseria
cobas CT/NG for use on cobas 6800/8800 systems
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Mar 21, 2018 |
| Received | Dec 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173887
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.