510(k) K013992 ยท CEW Radioimmunoassay, Parathyroid Hormone
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY
| Applicant | Nichols Institute Diagnostics, San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Dec 13, 2001 |
| Received | Dec 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013992
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.