510(k) K900546 ยท GTH Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT
| Applicant | Baxter Healthcare Corp, Bellevue WA, US |
| Decision | Substantially Equivalent, Jun 15, 1990 |
| Received | Feb 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900546
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.