510(k) K053289 ยท LSL Dna-Reagents, Neisseria
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 10, 2006 |
| Received | Nov 25, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053289
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.