510(k) K883305 ยท CGJ Radioimmunoassay, Follicle-Stimulating Hormone
BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY
| Applicant | Binax, Inc., S. Portland ME, US |
| Decision | Substantially Equivalent, Oct 6, 1988 |
| Received | Aug 4, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883305
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.