510(k) K862813 ยท CGJ Radioimmunoassay, Follicle-Stimulating Hormone
FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT
| Applicant | Serono Diagnostics, Inc., Norwell MA, US |
| Decision | Substantially Equivalent, Sep 16, 1986 |
| Received | Jul 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862813
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.