510(k) K070172 ยท LSL Dna-Reagents, Neisseria
AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
| Applicant | Roche Diagnostics Corporation, Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 17, 2007 |
| Received | Jan 18, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070172
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.