510(k) K871105 ยท LIC Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE
| Applicant | New Horizons Diagnostics Co., Columbia MD, US |
| Decision | Substantially Equivalent, May 13, 1987 |
| Received | Mar 19, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871105
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.