510(k) K822520 ยท JHI Visual, Pregnancy Hcg, Prescription Use
MODEL UCG ASSAY
| Applicant | Monoclonal Antibodies, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 28, 1982 |
| Received | Aug 23, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K822520
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.