510(k) K802660 ยท JHJ Agglutination Method, Human Chorionic Gonadotropin
ANSWER AT-HOME PREGNANCY TEST KIT
| Applicant | Armkel, LLC, Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 24, 1980 |
| Received | Oct 24, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802660
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.