510(k) K061509 ยท LSL Dna-Reagents, Neisseria
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196
| Applicant | Gen-Probe, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 4, 2006 |
| Received | Jun 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061509
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.