510(k) K911047 ยท JHI Visual, Pregnancy Hcg, Prescription Use
OBA(TM) SERUM HCG ASSAY
| Applicant | Adeza Biomedical, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 24, 1991 |
| Received | Mar 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911047
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.