510(k) K033727 ยท CEW Radioimmunoassay, Parathyroid Hormone
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
| Applicant | Nichols Institute Diagnostics, San Clemente CA, US |
| Decision | Substantially Equivalent, Apr 22, 2004 |
| Received | Nov 28, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033727
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2005 | Nichols Institute Diagnostics Bio-Intact PTH (1-84) Assay,
Catalog No. 62-7040 Terminated |
CEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.