510(k) K800328 ยท GTH Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
NEISSERIA GONORRHOEAE FLUORO-KIT
| Applicant | Clinical Sciences, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 3, 1980 |
| Received | Feb 12, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800328
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.