510(k) K810581 ยท JHJ Agglutination Method, Human Chorionic Gonadotropin
FACT* HOME PREGNANCY TEST
| Applicant | Ortho Pharmaceutical Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 17, 1981 |
| Received | Mar 3, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810581
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.