510(k) K970718 ยท JNM Immunochemical, Transferrin
QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
| Applicant | R&D Systems, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, May 27, 1997 |
| Received | Feb 26, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970718
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2021 | R & D Systems, Inc. Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Trans Terminated |
JNM | None listed |
| Nov 1, 2018 | R & D Systems, Inc. Quantikine IVD ELISA, Human sTfR Immunoassay kit.
Product Usage:
The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or Terminated |
JNM | None listed |
| Sep 26, 2016 | R & D Systems, Inc. R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTF Terminated |
JNM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.