510(k) K880511 ยท JSX Kit, Identification, Neisseria Gonorrhoeae
XACT NEISSERIA
| Applicant | Austin Biological Laboratories, Austin TX, US |
| Decision | Substantially Equivalent, Aug 25, 1988 |
| Received | Feb 9, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880511
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.