510(k) K811116 ยท JHI Visual, Pregnancy Hcg, Prescription Use
HCG RADIOIMMUNOASSAY
| Applicant | Hoffmann-La Roche, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, May 13, 1981 |
| Received | Apr 24, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811116
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.