510(k) K974306 ยท CEW Radioimmunoassay, Parathyroid Hormone
SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA
| Applicant | Sangui Biotech, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Dec 23, 1997 |
| Received | Nov 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974306
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 26, 2016 | Diagnostic Hybrids, Inc. Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum. Terminated |
CEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.