510(k) K821362 ยท LIC Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
IMPROVED GONO GEN
| Applicant | New Horizons Diagnostics Co. MD, US |
| Decision | Substantially Equivalent, Aug 4, 1982 |
| Received | May 7, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821362
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.