510(k) K894761 ยท CGJ Radioimmunoassay, Follicle-Stimulating Hormone
TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 13, 1989 |
| Received | Jul 27, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894761
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.