QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)— 510(k) K970718
Substantially EquivalentR&D Systems, Inc.
FDA 510(k) clearance K970718 for QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA), Substantially Equivalent on 1997-05-27. Applicant: R&D Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- R&D Systems, Inc.
- Product code
- Code JNM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5880
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code JNM
view allMore clearances from R&D Systems, Inc.
view allRecalls naming K970718
K-number listed on FDA's recall record- Z-1255-2021 — 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 Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia.
- Z-0691-2019 — 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 plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.
- Z-2887-2016 — R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970718.
Data sourced from openFDA. This site is unofficial and independent of the FDA.