510(k) K861835 ยท GTH Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST
| Applicant | Syva Co., Palo Alto CA, US |
| Decision | Substantially Equivalent, May 29, 1986 |
| Received | May 13, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861835
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.