510(k) K894175 ยท JHI Visual, Pregnancy Hcg, Prescription Use
SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY
| Applicant | Serono-Baker Diagnostics, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Dec 19, 1989 |
| Received | Jun 15, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894175
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.