510(k) K832562 ยท JHI Visual, Pregnancy Hcg, Prescription Use
SERUM HCG ASSAY
| Applicant | Monoclonal Antibodies, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 12, 1983 |
| Received | Aug 2, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K832562
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.