510(k) K864677 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP
| Applicant | Serono Diagnostics, Inc., Norwell MA, US |
| Decision | Substantially Equivalent, Jan 7, 1987 |
| Received | Dec 2, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864677
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.