510(k) K954418 ยท CEW Radioimmunoassay, Parathyroid Hormone
INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)
| Applicant | Nichols Institute Diagnostics, San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Nov 3, 1995 |
| Received | Sep 22, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954418
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.