510(k) K140887 ยท LSL Dna-Reagents, Neisseria
COBAS CT/NG V2.0 TEST
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, May 5, 2014 |
| Received | Apr 7, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140887
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.