510(k) K982491 ยท JKR Radioimmunoassay, Calcitonin
SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
| Applicant | Sangui Biotech, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Sep 3, 1998 |
| Received | Jul 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982491
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Biomerica Calcitonin ELISA Kit, Code No. 7024, 7024BU.
Intended use of this product is the quantitative determination of Calcitonin in human serum. Terminated |
JKR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.