510(k) K063664 ยท LSL Dna-Reagents, Neisseria
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091
| Applicant | Gen-Probe, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 25, 2007 |
| Received | Dec 8, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063664
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.